Trial Outcomes & Findings for BestFIT: a Personalized Weight Loss Program (NCT NCT02368002)
NCT ID: NCT02368002
Last Updated: 2021-12-03
Results Overview
Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
468 participants
Primary outcome timeframe
6 months and 18 months after baseline
Results posted on
2021-12-03
Participant Flow
26 participants were lost to follow-up or quit after the initial randomization to the 3 or 7 week treatment response assessment and prior to the treatment response assessment. These participants are included in the session 3 and session 7 treatment response assessment \& no-randomization groups.
Participant milestones
| Measure |
Session 3 Treatment Response Assessment
Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
|
Session 3 Treatment Response Assessment & ABT
Participants randomized to treatment response assessment at session 3 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to switch to ABT.
|
Session 3 Treatment Response Assessment & PCM
Participants randomized to treatment response assessment at session 3 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM.
|
Session 7 Treatment Response Assessment
Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
|
Session 7 Treatment Response Assessment & ABT
Participants randomized to treatment response assessment at session 7 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to switch to ABT.
|
Session 7 Treatment Response Assessment & PCM
Participants randomized to treatment response assessment at session 7 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM.
|
|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Up to 20 Weeks)
STARTED
|
233
|
0
|
0
|
235
|
0
|
0
|
|
Stage 1 Intervention (Up to 20 Weeks)
COMPLETED
|
228
|
0
|
0
|
214
|
0
|
0
|
|
Stage 1 Intervention (Up to 20 Weeks)
NOT COMPLETED
|
5
|
0
|
0
|
21
|
0
|
0
|
|
Stage 2 Intervention (Up to 17 Weeks)
STARTED
|
88
|
70
|
70
|
0
|
0
|
0
|
|
Stage 2 Intervention (Up to 17 Weeks)
COMPLETED
|
86
|
60
|
64
|
0
|
0
|
0
|
|
Stage 2 Intervention (Up to 17 Weeks)
NOT COMPLETED
|
2
|
10
|
6
|
0
|
0
|
0
|
|
Stage 2 Intervention (Up to 13 Weeks)
STARTED
|
0
|
0
|
0
|
95
|
57
|
62
|
|
Stage 2 Intervention (Up to 13 Weeks)
COMPLETED
|
0
|
0
|
0
|
94
|
53
|
59
|
|
Stage 2 Intervention (Up to 13 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
Baseline characteristics by cohort
| Measure |
Week 3 Treatment Response Assessment
n=233 Participants
Participants randomized to have their weight assessed at their 3rd session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment.
|
Week 7 Treatment Response Assessment
n=235 Participants
Participants randomized to have their weight assessed at their 7th session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment.
|
Portion Controlled Meals
n=132 Participants
Portion controlled meals: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to continue with behavioral weight loss therapy that is augmented with portion controlled meals (PCM).
|
Acceptance-based Treatment
n=127 Participants
Acceptance-based treatment: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to switching the therapeutic approach to an acceptance-based treatment.
|
Total
n=727 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Stage 1 Randomization · <=18 years
|
0 Participants
n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
0 Participants
n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
0 Participants
n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Age, Categorical
Stage 1 Randomization · Between 18 and 65 years
|
224 Participants
n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
225 Participants
n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
449 Participants
n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Age, Categorical
Stage 1 Randomization · >=65 years
|
9 Participants
n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
10 Participants
n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
19 Participants
n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Age, Categorical
Stage 2 Re-Randomization · <=18 years
|
—
|
—
|
0 Participants
n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
0 Participants
n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
0 Participants
n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Age, Categorical
Stage 2 Re-Randomization · Between 18 and 65 years
|
—
|
—
|
125 Participants
n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
125 Participants
n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
250 Participants
n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Age, Categorical
Stage 2 Re-Randomization · >=65 years
|
—
|
—
|
7 Participants
n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
2 Participants
n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
9 Participants
n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Sex: Female, Male
Stage 1 Randomization · Female
|
179 Participants
n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
178 Participants
n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
357 Participants
n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Sex: Female, Male
Stage 1 Randomization · Male
|
54 Participants
n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
57 Participants
n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
111 Participants
n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Sex: Female, Male
Stage 2 Re-Randomization · Female
|
—
|
—
|
111 Participants
n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
111 Participants
n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
222 Participants
n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Sex: Female, Male
Stage 2 Re-Randomization · Male
|
—
|
—
|
21 Participants
n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
16 Participants
n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
37 Participants
n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Race/Ethnicity, Customized
Stage 2 Re-Randomization · Hispanic, Any Race
|
—
|
—
|
4 Participants
n=132 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
8 Participants
n=127 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
12 Participants
n=259 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 1 Randomization · Non-Hispanic White
|
177 Participants
n=233 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
189 Participants
n=235 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
—
|
—
|
366 Participants
n=468 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 1 Randomization · Non-Hispanic Black
|
34 Participants
n=233 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
20 Participants
n=235 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
—
|
—
|
54 Participants
n=468 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 1 Randomization · Hispanic, Any Race
|
9 Participants
n=233 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
15 Participants
n=235 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
—
|
—
|
24 Participants
n=468 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 1 Randomization · Other
|
13 Participants
n=233 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
11 Participants
n=235 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
—
|
—
|
24 Participants
n=468 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 2 Re-Randomization · Non-Hispanic White
|
—
|
—
|
103 Participants
n=132 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
96 Participants
n=127 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
199 Participants
n=259 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 2 Re-Randomization · Non-Hispanic Black
|
—
|
—
|
18 Participants
n=132 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
15 Participants
n=127 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
33 Participants
n=259 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Race/Ethnicity, Customized
Stage 2 Re-Randomization · Other
|
—
|
—
|
7 Participants
n=132 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
8 Participants
n=127 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
15 Participants
n=259 Participants • Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.
|
|
Weight
Stage 1 Randomization
|
225.1 pounds
STANDARD_DEVIATION 34.82 • n=233 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
224.1 pounds
STANDARD_DEVIATION 34.25 • n=235 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
—
|
—
|
224.6 pounds
STANDARD_DEVIATION 34.50 • n=468 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
|
Weight
Stage 2 Re-Randomization
|
—
|
—
|
222.8 pounds
STANDARD_DEVIATION 34.55 • n=132 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
222 pounds
STANDARD_DEVIATION 33.37 • n=127 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
222.4 pounds
STANDARD_DEVIATION 33.91 • n=259 Participants • We report data for two periods: "Stage 1 Randomization" (initial randomization to Week 3 or Week 7 Treatment Response Assessment) and "Stage 2 Re-Randomization" (re-randomization of sub-optimal responders to Portion controlled meals or Acceptance-based treatment).
|
PRIMARY outcome
Timeframe: 6 months and 18 months after baselinePopulation: Participants included in this analysis were suboptimal responders to behavioral weight loss therapy whose initial treatment was augmented with portion-controlled meals or switched to acceptance-based treatment.
Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.
Outcome measures
| Measure |
Portion-controlled Meals
n=132 Participants
Portion-controlled meals: Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM).
|
Acceptance-based Treatment
n=127 Participants
Acceptance-based treatment: Participants switch to treatment teaching acceptance-based behavioral skills.
|
|---|---|---|
|
Weight Change
18M
|
-8.5 pounds
Interval -10.7 to -6.3
|
-7.4 pounds
Interval -9.7 to -5.2
|
|
Weight Change
6M
|
-18.4 pounds
Interval -20.5 to -16.2
|
-15.7 pounds
Interval -18.0 to -13.4
|
SECONDARY outcome
Timeframe: 6 and 18 months after baselinePopulation: Participants included in this analysis were all randomized participants, who had been randomly assigned to be assessed for treatment response 3 weeks (Early TRA) or 7 weeks (Late TRA) after initiating behavioral weight loss therapy.
Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.
Outcome measures
| Measure |
Portion-controlled Meals
n=233 Participants
Portion-controlled meals: Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM).
|
Acceptance-based Treatment
n=235 Participants
Acceptance-based treatment: Participants switch to treatment teaching acceptance-based behavioral skills.
|
|---|---|---|
|
Weight Change
|
-16.6 pounds
Interval -18.3 to -14.9
|
-16.7 pounds
Interval -18.4 to -15.0
|
Adverse Events
Week 3 Treatment Response Assessment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Week 7 Treatment Response Assessment
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Portion Controlled Meals
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Acceptance-based Treatment
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Week 3 Treatment Response Assessment
n=233 participants at risk
Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
|
Week 7 Treatment Response Assessment
n=235 participants at risk
Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
|
Portion Controlled Meals
n=132 participants at risk
Portion controlled meals: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to portion controlled meals.
|
Acceptance-based Treatment
n=127 participants at risk
Acceptance-based treatment: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to acceptance-based treatment.
|
|---|---|---|---|---|
|
Psychiatric disorders
Depressive disorders
|
0.00%
0/233 • 6 months
|
0.43%
1/235 • Number of events 1 • 6 months
|
0.00%
0/132 • 6 months
|
0.00%
0/127 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/233 • 6 months
|
0.43%
1/235 • Number of events 1 • 6 months
|
0.00%
0/132 • 6 months
|
0.00%
0/127 • 6 months
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/233 • 6 months
|
0.00%
0/235 • 6 months
|
0.00%
0/132 • 6 months
|
0.79%
1/127 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Ovarian cancer
|
0.00%
0/233 • 6 months
|
0.00%
0/235 • 6 months
|
0.76%
1/132 • Number of events 1 • 6 months
|
0.79%
1/127 • Number of events 1 • 6 months
|
|
General disorders
Dehydration & Hypertension
|
0.00%
0/233 • 6 months
|
0.43%
1/235 • Number of events 1 • 6 months
|
0.00%
0/132 • 6 months
|
0.00%
0/127 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place