Trial Outcomes & Findings for Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment (NCT NCT03779048)
NCT ID: NCT03779048
Last Updated: 2025-03-11
Results Overview
Co-primary outcomes - phase 1
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
147 participants
Primary outcome timeframe
Week -4 (start of BT run-in) to week 0 (randomization)
Results posted on
2025-03-11
Participant Flow
Recruitment occurred from July 2019 to November 2021. No participants could be enrolled between March 15, 2020 and July 1, 2020 due to COVID-19.
147 pts consented \& enrolled in phase 1. Of those, 16 did not enroll in phase 2: 7 did not complete \>=3 BT sessions, 5 could not complete a randomization visit due to COVID-19, 3 were lost to follow-up and 1 declined. 55 pts were early responders. For clinical purposes, these pts continued to receive BT for 24 weeks but because they were not eligible for randomization they were not part of the RCT. 76 pts were early non-responders (4-week weight loss \< 2%) randomized to BT+ placebo or BT+ med
Participant milestones
| Measure |
Phase 1 (4-week Non-randomized BT run-in)
The 147 participants that initially enrolled received 4 weeks of BT.
|
Phase 2: Behavioral Treatment + Placebo
Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Phase 2: Behavioral Treatment + Medication
Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: 4-week Non-randomized BT run-in
STARTED
|
147
|
0
|
0
|
|
Phase 1: 4-week Non-randomized BT run-in
COMPLETED
|
134
|
0
|
0
|
|
Phase 1: 4-week Non-randomized BT run-in
NOT COMPLETED
|
13
|
0
|
0
|
|
Phase 2: Randomized Trial
STARTED
|
0
|
38
|
38
|
|
Phase 2: Randomized Trial
COMPLETED
|
0
|
36
|
36
|
|
Phase 2: Randomized Trial
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 (4-week Non-randomized BT run-in)
The 147 participants that initially enrolled received 4 weeks of BT.
|
Phase 2: Behavioral Treatment + Placebo
Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Phase 2: Behavioral Treatment + Medication
Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: 4-week Non-randomized BT run-in
Lost to Follow-up
|
8
|
0
|
0
|
|
Phase 1: 4-week Non-randomized BT run-in
Could not complete visit due to COVID-19
|
5
|
0
|
0
|
|
Phase 2: Randomized Trial
Lost to Follow-up
|
0
|
2
|
2
|
Baseline Characteristics
Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment
Baseline characteristics by cohort
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=147 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Note: Data represent the baseline characteristics of all enrolled participants at the start of phase 1 (week -4). Only 76 participants were later eligible to enroll in the randomized trial.
|
|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Weight (kg)
|
104.6 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
BMI (kg/m2)
|
37.7 kg/m2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)Population: Percent weight loss at the end of the 4-week BT run-in (phase 1) for all 134 individuals who provided a weight measurement at the end of the run-in (week 0) and for the subset of 76 individuals who were categorized as early non-responders and then enrolled in the randomized trial (phase 2)
Co-primary outcomes - phase 1
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=134 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Percent Weight Loss
|
1.7 % change in weight
Standard Deviation 1.6
|
0.9 % change in weight
Standard Deviation 0.9
|
0.3 % change in weight
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)Population: 16 were not enrolled in Phase 2: 7 did not complete at least 3 BT sessions 5 could not complete a randomization visit due to COVID-19 3 were lost to follow-up 1 declined randomization
Co-primary outcomes - phase 1
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=131 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss
|
76 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (week -5)Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to participants whose VAS responses at baseline were not complete enough to be scored.
Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=138 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100.
|
787.3 Satiety quotient*min
Standard Deviation 684.9
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=125 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal
|
0.52 pM*hr
Standard Deviation 0.46
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 13 participants for whom we could not obtain at least one postprandial blood sample.
Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=126 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)
|
5.22 ug/mL*hr
Standard Deviation 3.39
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0 (randomization) to week 24Primary outcomes - phase 2 Percent change from randomization in body weight
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Percent Weight Loss
|
2.8 % change in weight
Standard Error 0.7
|
5.9 % change in weight
Standard Error 0.7
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the hunger scale score at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=139 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal
|
-770.97 score on a scale*min
Standard Deviation 1272.98
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). An additional 5 participants had missing data for this task at baseline.
Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=134 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned
|
1.85 Points (portions) earned
Standard Deviation 1.23
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=139 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay
|
0.34 dollar*day
Standard Deviation 0.23
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 2 participants due to their not completing the LFPQ at their baseline assessment
Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=137 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire
Implicit wanting of high-fat savory
|
7.0 Scale score
Standard Deviation 26.9
|
—
|
—
|
|
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire
Implicit wanting of high-fat sweet
|
-12.2 Scale score
Standard Deviation 27.7
|
—
|
—
|
|
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire
Implicit wanting of low-fat savory
|
-13.5 Scale score
Standard Deviation 23.6
|
—
|
—
|
|
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire
Implicit wanting of low-fat sweet
|
18.7 Scale score
Standard Deviation 28.1
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain a fasting blood sample or for whom fasting ghrelin results were out of range.
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL)
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=125 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Fasting Ghrelin
|
75.65 pg/mL
Standard Deviation 64.08
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 10 participants for whom we could not obtain a fasting blood sample or whose sample results were out of range.
Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting).
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=129 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Fasting Leptin
|
46980.6 pg/mL
Standard Deviation 38772.3
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=125 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Postprandial Change in Insulin During a Test Meal
|
20.96 ulU/mL*hr
Standard Deviation 13.08
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=125 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal
|
7.44 pg/mL*hr
Standard Deviation 7.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Secondary outcomes - phase 2
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Weight Loss (kg)
|
2.6 kg
Standard Error 0.7
|
5.7 kg
Standard Error 0.7
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Secondary outcomes - phase 2
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24
|
8 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Secondary outcomes - phase 2
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24
|
2 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Population: Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data.
Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=28 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=33 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal
Randomization
|
1167.7 mm*min
Standard Deviation 1124.8
|
1357.5 mm*min
Standard Deviation 1345.3
|
—
|
|
Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal
Week 24
|
862.8 mm*min
Standard Deviation 890.7
|
1245.3 mm*min
Standard Deviation 1072.9
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Population: Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data.
Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the scale score at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=28 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=33 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal
Randomization
|
-1062.5 mm*min
Standard Deviation 1139.8
|
-1113.2 mm*min
Standard Deviation 1294.6
|
—
|
|
Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal
Week 24
|
-579.5 mm*min
Standard Deviation 1530.6
|
-935.2 mm*min
Standard Deviation 1336.9
|
—
|
SECONDARY outcome
Timeframe: Week 0 (randomization) to week 24Population: Randomized participants who completed the study (N = 71 of 76) and also completed the delay discounting assessment at week 24 (N = 63 of 71).
Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=30 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=33 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay
Randomization
|
0.41 dollar*day
Standard Deviation 0.30
|
0.38 dollar*day
Standard Deviation 0.29
|
—
|
|
Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay
Week 24
|
0.42 dollar*day
Standard Deviation 0.31
|
0.38 dollar*day
Standard Deviation 0.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Eating Inventory scores for an additional 4 participants could not be calculated due to missing items
Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger)
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=135 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger)
EI Dietary Restraint
|
9.2 score on a scale
Standard Deviation 3.7
|
—
|
—
|
|
Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger)
EI Disinhibition
|
8.9 score on a scale
Standard Deviation 3.3
|
—
|
—
|
|
Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger)
EI Hunger
|
5.9 score on a scale
Standard Deviation 3.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=139 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency)
|
50.7 mm
Standard Deviation 12.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 6 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food)
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=133 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale
|
2.7 Scale score
Standard Deviation 0.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 5 participants due to missing items on the BIS-BAS scale
Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=134 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS)
BIS Total
|
14.2 Scale score
Standard Deviation 4.0
|
—
|
—
|
|
Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS)
BAS Reward
|
8.2 Scale score
Standard Deviation 2.2
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the BIS-15 scale
Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale
|
28.7 Scale score
Standard Deviation 6.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=131 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder
Potential BED
|
17 Participants
|
—
|
—
|
|
Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder
Potential subthreshold BED
|
6 Participants
|
—
|
—
|
|
Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder
Unlikely to have BED
|
108 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced
|
42.9 Scale score
Standard Deviation 15.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ)
|
2.7 Scale score
Standard Deviation 1.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=135 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012)
|
112.7 Scale score
Standard Deviation 25.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL)
|
44.4 Scale score
Standard Deviation 16.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES)
|
30.6 Scale score
Standard Deviation 5.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization (week 0)Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Participants were instructed not to answer items if not applicable to their household/lifestyle, resulting in fewer ppts completing this scale.
Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=118 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Randomization Ball and Crawford Social Support Scale
positive eating support from family
|
2.8 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Phase 1: Randomization Ball and Crawford Social Support Scale
negative eating support from family
|
2.4 score on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Phase 1: Randomization Ball and Crawford Social Support Scale
positive exercise support from family
|
2.1 score on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Phase 1: Randomization Ball and Crawford Social Support Scale
negative exercise support from family
|
1.2 score on a scale
Standard Deviation 0.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to missing item responses
Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=122 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS)
|
2.4 Symptom count
Standard Deviation 2.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 9 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=130 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food
High energy density snack
|
-0.99 (log)dollar/purchased serving
Standard Deviation 0.21
|
—
|
—
|
|
Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food
Low energy density snack
|
-1.03 (log)dollar/purchased serving
Standard Deviation 0.21
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Sleep Hours Survey
|
7.0 hours slept per night
Standard Deviation 1.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Perceived Stress Scale
|
15.8 Scale score
Standard Deviation 6.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=135 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline Anxiety as Measured by the GAD-7
|
4.4 Scale score
Standard Deviation 4.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=136 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale
Awareness
|
3.6 score on a scale
Standard Deviation 3.5
|
—
|
—
|
|
Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale
Acceptance
|
3.1 score on a scale
Standard Deviation 0.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2. Systolic blood pressure
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Blood Pressure (Systolic)
|
-0.7 mm Hg
Standard Error 1.84
|
6.6 mm Hg
Standard Error 1.86
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2. Pulse
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Pulse
|
0.09 BPM
Standard Error 1.56
|
3.96 BPM
Standard Error 1.50
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Triglycerides
|
-9.00 mg/dL
Standard Error 7.45
|
-16.00 mg/dL
Standard Error 7.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2. Reported here is HDL
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in HDL and LDL Cholesterol
|
3.27 mg/dL
Standard Error 1.49
|
1.52 mg/dL
Standard Error 1.37
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2. Fasting glucose.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Fasting Blood Sugar
|
1.00 mg/dL
Standard Error 1.81
|
-0.66 mg/dL
Standard Error 1.93
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Population: Randomized participants who completed the study (N = 71 of 76) and also completed the COEQ at week 24 (N = 65).
Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=30 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=35 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm)
Randomization
|
48.5 mm
Standard Deviation 14.3
|
53.3 mm
Standard Deviation 13.8
|
—
|
|
Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm)
Week 24
|
47.5 mm
Standard Deviation 16.8
|
42.7 mm
Standard Deviation 14.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL)
|
7.56 t score
Standard Error 2.18
|
9.77 t score
Standard Error 2.17
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9)
|
-0.68 units on a scale
Standard Error 0.55
|
-0.75 units on a scale
Standard Error 0.54
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (randomization) to week 24Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24.
Outcome measures
| Measure |
Phase 1: 4-week Behavioral Treatment Run-in
n=38 Participants
All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Only early non-responders will then be enrolled in the randomized trial.
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
|
Behavioral Treatment + Placebo
n=38 Participants
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
|---|---|---|---|
|
Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire
|
29.90 minutes per week
Standard Error 34.02
|
91.85 minutes per week
Standard Error 34.85
|
—
|
Adverse Events
Phase 1: 4-week BT run-in
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Behavioral Treatment + Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Behavioral Treatment + Medication
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Early Responders (Behavioral Treatment Alone)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: 4-week BT run-in
n=147 participants at risk
Adverse events occurring prior to randomization in the 147 participants who consented and enrolled in Phase 1 of the trial.
|
Behavioral Treatment + Placebo
n=38 participants at risk
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Behavioral Treatment + Medication
n=38 participants at risk
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
|
Early Responders (Behavioral Treatment Alone)
n=55 participants at risk
Early responders who lost \>2% during the BT run-in continued to receive behavioral treatment alone for 24 more weeks and were not assigned to receive study medication. They were not considered part of the randomized trial and adverse events were not assessed systematically, so frequencies cannot be compared directly to the randomized groups.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/38 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
3.6%
2/55 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
3.6%
2/55 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
7.9%
3/38 • Number of events 3 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
7.9%
3/38 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/55 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
7.3%
4/55 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Infections and infestations
Ear infection
|
0.68%
1/147 • Number of events 1 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
2.6%
1/38 • Number of events 1 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/55 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
General disorders
Headache
|
1.4%
2/147 • Number of events 3 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
15.8%
6/38 • Number of events 6 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.5%
3/55 • Number of events 3 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Injury
|
4.8%
7/147 • Number of events 9 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
10.5%
4/38 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
10.5%
4/38 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
7.3%
4/55 • Number of events 6 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Infections and infestations
Sinus infection
|
1.4%
2/147 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
10.5%
4/38 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/55 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
7/147 • Number of events 7 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
34.2%
13/38 • Number of events 15 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
10.5%
4/38 • Number of events 4 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
9.1%
5/55 • Number of events 5 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
General disorders
Reaction to COVID-19 vaccine
|
2.0%
3/147 • Number of events 3 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
2.6%
1/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
3.6%
2/55 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/147 • Number of events 1 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/38 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
1.8%
1/55 • Number of events 1 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Psychiatric disorders
Difficulty sleeping
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/38 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
7.9%
3/38 • Number of events 3 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
3.6%
2/55 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
General disorders
Dry mouth
|
0.00%
0/147 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/38 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
10.5%
4/38 • Number of events 6 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/55 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/147 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/38 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
5.3%
2/38 • Number of events 2 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
0.00%
0/55 • Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place