Stress and Eating Study

Binge-Eating Disorder Clinical Trial

Official title:

Acceptance-based Group Intervention for Binge Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757847
• Other study ID #: F7400-R
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: March 23, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately two-thirds of all adults and close to 75% of Veterans are overweight or obese, making obesity a national epidemic with significant impairments in physical and psychological functioning, increasing healthcare costs, and high mortality rates. A significant proportion of overweight and obese individuals binge eat in response to stress or negative emotions, further contributing to obesity. Obesity and binge eating are independently related to a number of physical and mental health co-morbidities such as diabetes, coronary heart disease, osteoarthritis, respiratory symptoms, depression, and anxiety. Although behavioral weight loss interventions have been partially effective, few show long-term maintenance of weight loss, especially for patients with binge eating behavior. Thus, a stepped-care approach that provides more intensive treatment to specifically address the emotional and behavioral factors associated with problematic eating and obesity may be necessary. Acceptance and Commitment Therapy (ACT), an empirically-supported intervention that is being rolled out nationally by the VA, 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 investigator's preliminary findings suggest that a brief ACT-based group intervention for patients with overweight or obesity can substantially reduce binge eating and distress, and improve functioning. This study proposes to test the efficacy of an ACT intervention for binge eating in conjunction with a standard behavioral weight loss intervention, Managing Overweight and/or Obesity for Veterans Everywhere (MOVE!), at the VA San Diego Healthcare System (VASDHS). Patients (N = 154) who are overweight or obese (body mass index > 25 kg/m2) and meet the clinical criteria for binge eating will be randomized to receive either four 2-hour weekly ACT intervention groups or brief MOVE-II active control groups after their participation in MOVE!. This study hypothesizes that: 1) patients in the ACT intervention will experience significantly greater reductions in binge eating severity than patients in the brief MOVE-II active control group (primary outcome); 2) patients in the ACT intervention will experience significantly greater improvements in physical and mental health functioning, obesity-related quality of life, physical activity levels, caloric and nutrient intake, emotional distress symptoms, binge frequency, and other forms of emotional eating than patients in the brief MOVE-II active control group; 3) gains associated with the ACT intervention will be maintained longer than gains associated with the brief MOVE-II active control group; 4) at 3-month and 6-month follow-ups, patients in the ACT intervention will have greater decreases in body mass index compared to patients in the brief MOVE-II active control group; and 5) measures of acceptance and action will mediate treatment response in the ACT intervention on outcomes of interest. Given the significant physical and psychological sequelae of binge eating and obesity, a brief intervention that can reduce disordered eating, enhance the maintenance of weight loss, and improve functioning among patients who suffer from binge eating, could be critical in the comprehensive approach to patient care at the VA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy (ACT), an empirically-supported intervention that is being rolled out nationally by the VA, 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 investigator's preliminary findings suggest that a brief ACT-based group intervention for patients with overweight or obesity can substantially reduce binge eating and distress, and improve functioning.
• Brief MOVE-II 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 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	post treatment (4 weeks), 3 months, 6 months	No
Secondary	Change from Baseline in The Dutch Eating Behavior Questionnaire (DEBQ) at 4 weeks, 3 months, and 6 months	The DEBQ is a 33-item self-report scale. The DEBQ contains 3 subscales, assessing restrained, emotional and external eating behavior.	post treatment (4 weeks), 3 months, 6 months	No
Secondary	Change from Baseline in The Short Form Health Survey, Version 2 (SF-36, v.2) at 4 weeks, 3 months, and 6 months	The SF-36, v2 is a widely used measure to assess health related quality of life in populations with medical issues and chronic disease. The SF-36 includes one multi-item scale that assesses eight health concepts: 1)limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health; 6) limitations in usual role activities because of emotional problems; 7) vitality; and 8) general health perceptions	post treatment (4 weeks), 3 months, 6 months	No
Secondary	Change from Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 weeks, 3 months, and 6 months	The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. Factor analysis has identified the 2 subscales of psychological status and social adjustment, and physical symptoms impairment.	post treatment (4 weeks), 3 months, 6 months	No