Trial Outcomes & Findings for Improving Weight Loss Outcomes for Binge Eating Disorder. (NCT NCT03712462)
NCT ID: NCT03712462
Last Updated: 2024-04-26
Results Overview
Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)
Results posted on
2024-04-26
Participant Flow
Participant milestones
| Measure |
ABBT Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
|
Standard Behavior Therapy
Standard Behavioral Weight Loss Therapy
Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data for two participants from ABT and two participants from SBT.
Baseline characteristics by cohort
| Measure |
ABBT Weight Loss Therapy for BED
n=63 Participants
Acceptance-Based Behavioral Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
|
Standard Behavior Therapy
n=63 Participants
Standard Behavioral Weight Loss Therapy
Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.56 years
STANDARD_DEVIATION 12.41 • n=63 Participants
|
51.05 years
STANDARD_DEVIATION 11.60 • n=63 Participants
|
51.30 years
STANDARD_DEVIATION 11.96 • n=126 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=61 Participants • Missing data for two participants from ABT and two participants from SBT.
|
49 Participants
n=61 Participants • Missing data for two participants from ABT and two participants from SBT.
|
100 Participants
n=122 Participants • Missing data for two participants from ABT and two participants from SBT.
|
|
Sex: Female, Male
Male
|
10 Participants
n=61 Participants • Missing data for two participants from ABT and two participants from SBT.
|
12 Participants
n=61 Participants • Missing data for two participants from ABT and two participants from SBT.
|
22 Participants
n=122 Participants • Missing data for two participants from ABT and two participants from SBT.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=63 Participants
|
1 Participants
n=63 Participants
|
3 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=63 Participants
|
54 Participants
n=63 Participants
|
112 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=63 Participants
|
8 Participants
n=63 Participants
|
11 Participants
n=126 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=63 Participants
|
1 Participants
n=63 Participants
|
2 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=63 Participants
|
15 Participants
n=63 Participants
|
31 Participants
n=126 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=63 Participants
|
44 Participants
n=63 Participants
|
88 Participants
n=126 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=63 Participants
|
3 Participants
n=63 Participants
|
5 Participants
n=126 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=63 Participants
|
63 participants
n=63 Participants
|
126 participants
n=126 Participants
|
|
Baseline EDE Global Score
|
2.29 scores on a scale
STANDARD_DEVIATION 0.68 • n=63 Participants
|
1.72 scores on a scale
STANDARD_DEVIATION 0.76 • n=63 Participants
|
2.01 scores on a scale
STANDARD_DEVIATION 0.72 • n=126 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline).
Outcome measures
| Measure |
ABBT Weight Loss Therapy for BED
n=63 Participants
Acceptance-Based Behavioral Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
|
Standard Behavior Therapy
n=63 Participants
Standard Behavioral Weight Loss Therapy
Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
|
|---|---|---|
|
Weight Loss
Baseline
|
0 percentage of weight loss
Standard Deviation 0
|
0 percentage of weight loss
Standard Deviation 0
|
|
Weight Loss
1 Month
|
-2.13 percentage of weight loss
Standard Deviation 3.68
|
-2.15 percentage of weight loss
Standard Deviation 2.85
|
|
Weight Loss
3 Months
|
-5.46 percentage of weight loss
Standard Deviation 5.41
|
-5.25 percentage of weight loss
Standard Deviation 4.32
|
|
Weight Loss
6 Months
|
-7.65 percentage of weight loss
Standard Deviation 7.37
|
-6.97 percentage of weight loss
Standard Deviation 5.92
|
|
Weight Loss
Post-Treatment
|
-7.46 percentage of weight loss
Standard Deviation 9.67
|
-7.06 percentage of weight loss
Standard Deviation 7.42
|
|
Weight Loss
1 Year Follow-Up
|
-4.76 percentage of weight loss
Standard Deviation 9.01
|
-3.52 percentage of weight loss
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint. Assessing changes in EDE Global score.
Outcome measures
| Measure |
ABBT Weight Loss Therapy for BED
n=63 Participants
Acceptance-Based Behavioral Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
|
Standard Behavior Therapy
n=63 Participants
Standard Behavioral Weight Loss Therapy
Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
|
|---|---|---|
|
Eating Disorder Examination Questionnaire
Baseline
|
2.29 score on a scale
Standard Deviation 0.68
|
1.72 score on a scale
Standard Deviation 0.76
|
|
Eating Disorder Examination Questionnaire
Post-Treatment
|
2.49 score on a scale
Standard Deviation 0.77
|
1.49 score on a scale
Standard Deviation 0.78
|
|
Eating Disorder Examination Questionnaire
1 Year Follow-Up
|
1.50 score on a scale
Standard Deviation 0.70
|
1.60 score on a scale
Standard Deviation 0.81
|
Adverse Events
ABBT Weight Loss Therapy for BED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Behavior Therapy
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