Acceptance-based Group Intervention for Binge Eating

NCT01757847 | Completed Results

• 1 other identifier: F7400-R
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group intervention to an active control group in a sample of 154 overweight or obese binge eating Veterans who have completed the VA's national behavioral weight management program (MOVE!). This study anticipates that the ACT intervention will reduce binge eating and distress while improving functioning and maintenance of weight loss.

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder; Obesity; emotional eating

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months

  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.

  post treatment (4 weeks), 3 months, 6 months

Secondary Outcomes (1)

• Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months

  post treatment (4 weeks), 3 months, 6 months

Study Arms (2)

Brief MOVE-II active control group intervention

ACTIVE COMPARATOR

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. 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 by exploring patient strengths and maintaining therapeutic alliance and optimism. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions to patient with overweight or obesity who have completed the VA San Diego MOVE program.

Behavioral: Brief MOVE-II control group intervention

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Acceptance and Commitment Therapy (ACT), has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The ACT protocol for this study focuses on reducing binge eating and distress and improving functioning in individual who are overweight or obese. The protocol focuses 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. The protocol will be delivered in four 2-hour weekly group sessions to patients with overweight or obesity who have completed the VA San Diego MOVE program.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

Also known as: ACT

Acceptance and Commitment Therapy (ACT)

Brief MOVE-II control group intervention BEHAVIORAL

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 will be 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 to reinforcing the strategies taught during MOVE! and to provide support in implementing those strategies, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism.

Brief MOVE-II active control group intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of overweight or obesity (i.e., BMI \> 25 kg/m2), as verified by a study physician after a medical evaluation and examination of medical records;
• Attendance of at least 60% of weight loss sessions of the MOVE! program (i.e., 5 of 8 sessions).
• At least 18 years old

You may not qualify if:

• Serious or unstable medical or psychiatric illness (i.e., current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation;
• Conditions in which exercise or weight loss will be detrimental to one's health (e.g., pregnancy);
• Active suicidal ideation or history of suicide attempt within 5 years;
• Pharmacotherapy for obesity (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 6 months;
• Current participation in group or individual psychotherapy for weight management or binge eating;
• Previous treatment with ACT;
• Unwillingness to agree not to change professionally delivered mood treatments and psychotherapy (e.g., begin new therapy or group; discontinue a treatment; increase the dose of medication) for the duration of 4-week study treatment period unless medically necessary.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (2)

• Morse JL, Fishbein JN, Wooldridge JS, Herbert MS, Afari N. Posttraumatic Stress Disorder and Weight Loss in Male and Female Active-duty Service Members: A Weight Management Study. Mil Med. 2025 Sep 1;190(9-10):e1784-e1791. doi: 10.1093/milmed/usae561.

  PMID: 39797515 DERIVED

• Afari N, Herbert MS, Godfrey KM, Cuneo JG, Salamat JS, Mostoufi S, Gasperi M, Ober K, Backhaus A, Rutledge T, Wetherell JL. Acceptance and commitment therapy as an adjunct to the MOVE! programme: a randomized controlled trial. Obes Sci Pract. 2019 Aug 16;5(5):397-407. doi: 10.1002/osp4.356. eCollection 2019 Oct.

  PMID: 31687165 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity; Emotional Eating

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Niloofar Afari, PhD
• Organization: VA San Diego Healthcare System

niloofar.afari@va.gov

858-642-3387

Study Officials

• Niloofar Afari, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 31, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 21, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)