Trial Outcomes & Findings for Empowered With Movement to Prevent Obesity and Weight Regain (NCT NCT02923674)
NCT ID: NCT02923674
Last Updated: 2022-03-23
Results Overview
Measured in clinic on the same scale
COMPLETED
NA
183 participants
Baseline
2022-03-23
Participant Flow
Participant milestones
| Measure |
Weight Loss + Exercise + Sitless
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Weight Loss + Sitless
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
63
|
|
Overall Study
COMPLETED
|
32
|
32
|
38
|
|
Overall Study
NOT COMPLETED
|
28
|
28
|
25
|
Reasons for withdrawal
| Measure |
Weight Loss + Exercise + Sitless
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Weight Loss + Sitless
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
|---|---|---|---|
|
Overall Study
Clinic Closed Due to COVID-19
|
14
|
11
|
14
|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
7
|
|
Overall Study
Problem with intervention
|
2
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
Baseline Characteristics
Empowered With Movement to Prevent Obesity and Weight Regain
Baseline characteristics by cohort
| Measure |
Weight Loss + Exercise + Sitless
n=60 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Sitless
n=63 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=60 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
63 participants
n=7 Participants
|
60 participants
n=5 Participants
|
183 participants
n=4 Participants
|
|
Education (>High School)
|
57 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Cognitive Status (MoCA) Score
|
26.2 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
25.86 units on a scale
STANDARD_DEVIATION 2.27 • n=4 Participants
|
|
Depression (CES-D) Score
|
6.4 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
6.48 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
6.31 units on a scale
STANDARD_DEVIATION 5.57 • n=4 Participants
|
|
Height
|
165.0 cm
STANDARD_DEVIATION 7.5 • n=5 Participants
|
165.4 cm
STANDARD_DEVIATION 9.3 • n=7 Participants
|
162.2 cm
STANDARD_DEVIATION 8.9 • n=5 Participants
|
164.3 cm
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Body Mass
|
96.8 kg
STANDARD_DEVIATION 12.8 • n=5 Participants
|
97.2 kg
STANDARD_DEVIATION 14.3 • n=7 Participants
|
94.3 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
95.8 kg
STANDARD_DEVIATION 13.9 • n=4 Participants
|
|
Body Mass Index
|
35.4 kg/m^2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
35.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
35.5 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
35.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=4 Participants
|
|
Waist to Hip Ratio
|
0.88 ratio
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.90 ratio
STANDARD_DEVIATION 0.09 • n=7 Participants
|
0.88 ratio
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.9 ratio
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Gait Speed
|
1.00 m/sec
STANDARD_DEVIATION 0.17 • n=5 Participants
|
1.03 m/sec
STANDARD_DEVIATION 0.19 • n=7 Participants
|
1.00 m/sec
STANDARD_DEVIATION 0.16 • n=5 Participants
|
1.0 m/sec
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Short Physical Performance Battery (SPPB) Score
|
10.8 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
|
Expanded Short Physical Performance Battery (eSPPB) Score
|
2.2 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Aerobic fitness
|
22.2 VO2peak; ml/kg/min
STANDARD_DEVIATION 4.8 • n=5 Participants
|
20.3 VO2peak; ml/kg/min
STANDARD_DEVIATION 5.0 • n=7 Participants
|
21.2 VO2peak; ml/kg/min
STANDARD_DEVIATION 3.9 • n=5 Participants
|
20.6 VO2peak; ml/kg/min
STANDARD_DEVIATION 4.1 • n=4 Participants
|
|
Resting Seated Blood Pressure--Systolic
|
132 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
135 mmHg
STANDARD_DEVIATION 12 • n=7 Participants
|
135 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
134.8 mmHg
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Resting Seated Blood Pressure Diastolic
|
82 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
81 mmHg
STANDARD_DEVIATION 8 • n=7 Participants
|
82 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
82 mmHg
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Self-reported comorbidity Hypertension
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Self-reported comorbidity Diabetes
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Self-reported comorbidity Sleep Apnea
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Self-reported comorbidity Osteoarthritis
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Self-reported comorbidity Osteopenia
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Anti-hypertensive Medication use
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Cholesterol-lowering Medication use
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Glucose control Medication use
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Anti-depressant/mood Medication use
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.
Measured in clinic on the same scale
Outcome measures
| Measure |
Weight Loss + Exercise + Sitless
n=26 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=31 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Weight Loss + Sitless
n=31 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
|---|---|---|---|
|
Body Weight
|
94.7 kg
Standard Deviation 10.2
|
91.6 kg
Standard Deviation 14.3
|
95.1 kg
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.
Measured in clinic on the same scale
Outcome measures
| Measure |
Weight Loss + Exercise + Sitless
n=26 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=31 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Weight Loss + Sitless
n=33 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
|---|---|---|---|
|
Body Weight
|
86.9 kg
Standard Deviation 12.4
|
82.8 kg
Standard Deviation 11.4
|
87.0 kg
Standard Deviation 13.3
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.
Measured in clinic on the same scale
Outcome measures
| Measure |
Weight Loss + Exercise + Sitless
n=26 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=31 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
Weight Loss + Sitless
n=33 Participants
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
|---|---|---|---|
|
Body Weight
|
89.8 kg
Standard Deviation 14.3
|
87.2 kg
Standard Deviation 13.1
|
88.7 kg
Standard Deviation 14.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (0mo), 6mo, 18mo13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moDAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18mo10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function. A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moA 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moSelf-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moA scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moUsed to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moScale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18mo15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moScale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moA questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18mo15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6mo, 18moAdministered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 mo, 18 moAdministered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moThree anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moConsists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moTest is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moMeasured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moThe Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moA facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moUsed to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPAL™ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6moUsed to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly".
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moTest is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moUsed to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moA visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moHip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moAn 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo, 18moScale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance.
Outcome measures
Outcome data not reported
Adverse Events
Weight Loss + Exercise + Sitless
Weight Loss + Sitless
Weight Loss + Exercise
Serious adverse events
| Measure |
Weight Loss + Exercise + Sitless
n=60 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Sitless
n=63 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=60 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Takatsubu cardiomyopathy
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Complication of laparoscopic banding
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Post Viral Neuropathy
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Gastric sleeve procedure
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Knee replacement
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Brain aneurysm
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal benign mass
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
Other adverse events
| Measure |
Weight Loss + Exercise + Sitless
n=60 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Sitless
n=63 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level \<3).
|
Weight Loss + Exercise
n=60 participants at risk
Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
hypertension
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Aneurysm
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Takatsubu cardiomyopathy
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
6.7%
4/60 • Number of events 4 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 2 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Capsulitis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Achilles tendonitis
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Knee sprain
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Ankle Sprain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
TMJ pain
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 4 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Musculoskeletal and connective tissue disorders
Dental Crown Replacement
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Ulcerative colitis
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Upper respiratory infection
|
3.3%
2/60 • Number of events 3 • Baseline through month 18
|
3.2%
2/63 • Number of events 2 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Infections and infestations
Bronchial infection
|
8.3%
5/60 • Number of events 6 • Baseline through month 18
|
3.2%
2/63 • Number of events 2 • Baseline through month 18
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
|
Infections and infestations
Influenza
|
6.7%
4/60 • Number of events 4 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
5.0%
3/60 • Number of events 3 • Baseline through month 18
|
|
Infections and infestations
Sinusitis
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
3.3%
2/60 • Number of events 3 • Baseline through month 18
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/60 • Baseline through month 18
|
3.2%
2/63 • Number of events 2 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Lung infection
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Nail infection
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Bacterial gastroenteritis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Herpes zoster
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Tooth infection
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Vaginal infection (fungal)
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Viral infection
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Infections and infestations
Prostate infection
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Infections and infestations
Lyme disease
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
4.8%
3/63 • Number of events 5 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
fracture
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Foot injury
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Complication of laparoscopic banding
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Car/Motor vehicle accident
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Vaccine reaction
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Medication Side Effect
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retro-peritoneal mass
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell skin cancer
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Presyncope
|
1.7%
1/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Paresthesia
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Vasovagal reaction
|
1.7%
1/60 • Number of events 2 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Multiple sclerosis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Stenosis of branch of left middle cerebral
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Light headed
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Post viral neuropathy
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Skin and subcutaneous tissue disorders
Cyst
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
3.2%
2/63 • Number of events 2 • Baseline through month 18
|
3.3%
2/60 • Number of events 2 • Baseline through month 18
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Ear and labyrinth disorders
Eustachian tube infection
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Eye disorders
cataracts
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Ear and labyrinth disorders
retinal vascular disorder
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Renal and urinary disorders
Hematuria
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Hip replacement
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Surgical and medical procedures
Bilateral blepharoplasty
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Carpal tunnel surgery
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Cataract surgery
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 2 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Epidural injection
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Surgical and medical procedures
Excision of skin cancers
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Gastric sleeve procedure
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Joint injection
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Surgical and medical procedures
Saphenous vein ablation
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Surgical and medical procedures
Phlebotomy
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Surgical and medical procedures
Knee replacement
|
0.00%
0/60 • Baseline through month 18
|
3.2%
2/63 • Number of events 2 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Hernia repair
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Achilles tendon repair
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Removal of ingrown toe nail
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
General disorders
Dehydration
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Nervous system disorders
Brain aneurysm
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
General disorders
Fatigue
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
General disorders
Fever
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Gastrointestinal disorders
Gallbladder pain
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
|
Immune system disorders
allergic reaction
|
0.00%
0/60 • Baseline through month 18
|
0.00%
0/63 • Baseline through month 18
|
1.7%
1/60 • Number of events 1 • Baseline through month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal benign mass
|
0.00%
0/60 • Baseline through month 18
|
1.6%
1/63 • Number of events 1 • Baseline through month 18
|
0.00%
0/60 • Baseline through month 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place