Clinical trial NCT01757847: Acceptance-based Group Intervention for Binge Eating
Official title: Acceptance-based Group Intervention for Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Binge-Eating Disorder
Obesity
emotional eating
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-12-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
timeFrame: post treatment (4 weeks), 3 months, 6 months
Secondary outcomes:
measure: Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
timeFrame: post treatment (4 weeks), 3 months, 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Niloofar Afari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.