Trial Outcomes & Findings for Testing Intervention Strategies for Addressing Obesity and Binge Eating (NCT NCT04771455)
NCT ID: NCT04771455
Last Updated: 2024-09-19
Results Overview
Changes in weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Measured at baseline, post-intervention (16-weeks)
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Condition 1
Behavioral weight loss intervention
Behavioral weight loss: Participants will receive behavioral weight loss intervention
|
Condition 2
Behavioral weight loss intervention and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 3
Behavioral weight loss intervention and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
|
Condition 4
Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 5
Behavioral weight loss intervention and decrease overvaluation of weight and shape
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
|
Condition 6
Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 7
Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
|
Condition 8
Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
11
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
9
|
11
|
8
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Intervention Strategies for Addressing Obesity and Binge Eating
Baseline characteristics by cohort
| Measure |
Condition 1
n=10 Participants
Behavioral weight loss intervention
Behavioral weight loss: Participants will receive behavioral weight loss intervention
|
Condition 2
n=10 Participants
Behavioral weight loss intervention and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 3
n=10 Participants
Behavioral weight loss intervention and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
|
Condition 4
n=10 Participants
Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 5
n=11 Participants
Behavioral weight loss intervention and decrease overvaluation of weight and shape
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
|
Condition 6
n=10 Participants
Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Condition 7
n=10 Participants
Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
|
Condition 8
n=10 Participants
Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 18.2 • n=4 Participants
|
48.1 years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
41.2 years
STANDARD_DEVIATION 13.5 • n=8 Participants
|
42.1 years
STANDARD_DEVIATION 15.5 • n=8 Participants
|
47.3 years
STANDARD_DEVIATION 17.3 • n=24 Participants
|
43.4 years
STANDARD_DEVIATION 15.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
62 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
64 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, post-intervention (16-weeks)Changes in weight
Outcome measures
| Measure |
Overvaluation of Weight/Shape (Yes)
n=41 Participants
Received the overvaluation of weight/shape intervention component
|
Overvaluation of Weight/Shape (no)
n=40 Participants
Did not receive the overvaluation of weight/shape intervention component
|
Unhealthy Weight Control Practices (Yes)
n=40 Participants
Received the unhealthy weight control practices intervention component
|
Unhealthy Weight Control Practices (no)
n=41 Participants
Did not receive the unhealthy weight control practices intervention component
|
Negative Affect (Yes)
n=40 Participants
Received the negative affect intervention component
|
Negative Affect (no)
n=41 Participants
Did not receive the negative affect intervention component
|
|---|---|---|---|---|---|---|
|
Weight
|
4.2 pounds
Standard Deviation 21.9
|
6.9 pounds
Standard Deviation 21.3
|
4.7 pounds
Standard Deviation 22.6
|
6.3 pounds
Standard Deviation 20.7
|
8.5 pounds
Standard Deviation 27.7
|
2.7 pounds
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Measured at baseline, post-intervention (16-weeks)Changes in episodes of binge eating (past 28 days)
Outcome measures
| Measure |
Overvaluation of Weight/Shape (Yes)
n=41 Participants
Received the overvaluation of weight/shape intervention component
|
Overvaluation of Weight/Shape (no)
n=40 Participants
Did not receive the overvaluation of weight/shape intervention component
|
Unhealthy Weight Control Practices (Yes)
n=40 Participants
Received the unhealthy weight control practices intervention component
|
Unhealthy Weight Control Practices (no)
n=41 Participants
Did not receive the unhealthy weight control practices intervention component
|
Negative Affect (Yes)
n=40 Participants
Received the negative affect intervention component
|
Negative Affect (no)
n=41 Participants
Did not receive the negative affect intervention component
|
|---|---|---|---|---|---|---|
|
Binge Eating Episodes
|
8.1 Change in number of episodes
Standard Deviation 10.9
|
10.1 Change in number of episodes
Standard Deviation 13.7
|
6.9 Change in number of episodes
Standard Deviation 8.5
|
11.2 Change in number of episodes
Standard Deviation 15.0
|
9.8 Change in number of episodes
Standard Deviation 11.1
|
8.4 Change in number of episodes
Standard Deviation 13.5
|
Adverse Events
Condition 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place