CHARGE: Controlling Hunger and ReGulating Eating

University of California San Diego

Status

Completed

Conditions

Binge-Eating Disorder

Overweight

Obesity

Treatments

Behavioral: Cognitive Behavior Therapy (CBT)

Behavioral: Regulation of Cues (ROC)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03678766

181015

Details and patient eligibility

About

The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).

Full description

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators will recruit and randomize 120 male and female Veterans with BED and subclinical BED with comorbid overweight/obesity, provide 5 months of treatment and follow participants for 6-months post-treatment. Participants will complete assessments at baseline, mid-treatment (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the first to contribute to a body of literature developing treatments for BED and overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.

Enrollment

129 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
Participants will be willing to maintain contact with the investigators for 11 months.
Participants will be free of serious or unstable medical (current symptoms of angina, stroke, heart disease or other serious medical condition that would make physical activity unsafe or impossible at a moderate level) or psychiatric illness (i.e., active suicidal ideation, history of suicide attempt within 1 year, 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.
Participants will be free from conditions in which exercise or weight loss will be detrimental to the participant's health (e.g., pregnancy); pharmacotherapy for obesity or binge eating disorder (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 11 months.
Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.