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Acceptance-based Group Intervention for Binge Eating

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ClinicalTrials.gov Identifier: NCT01757847
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : October 6, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Binge-Eating Disorder
Interventions Behavioral: Acceptance and Commitment Therapy (ACT)
Behavioral: Brief MOVE-II control group intervention
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 44 46
Completed 41 42
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             3             4
Arm/Group Title Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT) Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 44 46 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 46 participants 90 participants
57.52  (9.33) 56.23  (10.34) 56.87  (9.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 46 participants 90 participants
Female
7
  15.9%
13
  28.3%
20
  22.2%
Male
37
  84.1%
33
  71.7%
70
  77.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 46 participants 90 participants
Hispanic or Latino
2
   4.5%
6
  13.0%
8
   8.9%
Not Hispanic or Latino
42
  95.5%
40
  87.0%
82
  91.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 46 participants 90 participants
American Indian or Alaska Native
1
   2.3%
2
   4.3%
3
   3.3%
Asian
0
   0.0%
1
   2.2%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  22.7%
7
  15.2%
17
  18.9%
White
32
  72.7%
36
  78.3%
68
  75.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.3%
0
   0.0%
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 46 participants 90 participants
44 46 90
Binge Eating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 46 participants 90 participants
17.48  (8.25) 15.53  (9.28) 16.47  (8.80)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
Hide Description 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.
Time Frame post treatment (4 weeks), 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants with measurement at baseline and at least one other time point.
Arm/Group Title Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 42 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.38  (8.15) 15.45  (9.19)
Post treatment 10.52  (7.29) 13.52  (9.05)
3 month follow up 10.47  (7.40) 11.90  (8.65)
6 month follow up 10.00  (7.49) 12.20  (7.32)
2.Secondary Outcome
Title Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
Hide Description 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.
Time Frame post treatment (4 weeks), 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at baseline and at least one other time point.
Arm/Group Title Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 42 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 50.17  (28.26) 49.47  (30.60)
Post Treatment 41.86  (22.65) 46.02  (33.57)
3 month follow up 41.07  (26.77) 38.79  (29.14)
6 month follow up 37.90  (31.87) 36.55  (27.82)
Time Frame Duration of study up to the 6-month follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brief MOVE-II Active Control Group Intervention Acceptance and Commitment Therapy (ACT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/46 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Niloofar Afari, PhD
Organization: VA San Diego Healthcare System
Phone: 858-642-3387
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01757847     History of Changes
Other Study ID Numbers: F7400-R
First Submitted: December 11, 2012
First Posted: December 31, 2012
Results First Submitted: August 10, 2016
Results First Posted: October 6, 2016
Last Update Posted: November 21, 2016