Trial Outcomes & Findings for Acceptance-based Group Intervention for Binge Eating (NCT NCT01757847)
NCT ID: NCT01757847
Last Updated: 2016-11-21
Results Overview
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
post treatment (4 weeks), 3 months, 6 months
Results posted on
2016-11-21
Participant Flow
Participant milestones
| Measure |
Brief MOVE-II Active Control Group Intervention
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
|
Acceptance and Commitment Therapy (ACT)
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Brief MOVE-II Active Control Group Intervention
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
|
Acceptance and Commitment Therapy (ACT)
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Acceptance-based Group Intervention for Binge Eating
Baseline characteristics by cohort
| Measure |
Brief MOVE-II Active Control Group Intervention
n=44 Participants
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
|
Acceptance and Commitment Therapy (ACT)
n=46 Participants
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.52 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
56.23 years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
56.87 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
46 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Binge Eating Scale
|
17.48 units on a scale
STANDARD_DEVIATION 8.25 • n=5 Participants
|
15.53 units on a scale
STANDARD_DEVIATION 9.28 • n=7 Participants
|
16.47 units on a scale
STANDARD_DEVIATION 8.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: post treatment (4 weeks), 3 months, 6 monthsPopulation: participants with measurement at baseline and at least one other time point.
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Outcome measures
| Measure |
Brief MOVE-II Active Control Group Intervention
n=42 Participants
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
|
Acceptance and Commitment Therapy (ACT)
n=43 Participants
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
|
|---|---|---|
|
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
Baseline
|
17.38 units on a scale
Standard Deviation 8.15
|
15.45 units on a scale
Standard Deviation 9.19
|
|
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
Post treatment
|
10.52 units on a scale
Standard Deviation 7.29
|
13.52 units on a scale
Standard Deviation 9.05
|
|
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
3 month follow up
|
10.47 units on a scale
Standard Deviation 7.40
|
11.90 units on a scale
Standard Deviation 8.65
|
|
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
6 month follow up
|
10.00 units on a scale
Standard Deviation 7.49
|
12.20 units on a scale
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: post treatment (4 weeks), 3 months, 6 monthsPopulation: Participants with measurement at baseline and at least one other time point.
The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.
Outcome measures
| Measure |
Brief MOVE-II Active Control Group Intervention
n=42 Participants
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
|
Acceptance and Commitment Therapy (ACT)
n=43 Participants
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
|
|---|---|---|
|
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
Baseline
|
50.17 units on a scale
Standard Deviation 28.26
|
49.47 units on a scale
Standard Deviation 30.60
|
|
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
Post Treatment
|
41.86 units on a scale
Standard Deviation 22.65
|
46.02 units on a scale
Standard Deviation 33.57
|
|
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
3 month follow up
|
41.07 units on a scale
Standard Deviation 26.77
|
38.79 units on a scale
Standard Deviation 29.14
|
|
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
6 month follow up
|
37.90 units on a scale
Standard Deviation 31.87
|
36.55 units on a scale
Standard Deviation 27.82
|
Adverse Events
Brief MOVE-II Active Control Group Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acceptance and Commitment Therapy (ACT)
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