CHARGE: Controlling Hunger and ReGulating Eating
- Conditions
- ObesityBinge-Eating DisorderOverweight
- Interventions
- Behavioral: Cognitive Behavior Therapy (CBT)Behavioral: Regulation of Cues (ROC)
- Registration Number
- NCT03678766
- Lead Sponsor
- University of California, San Diego
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavior Therapy (CBT) Cognitive Behavior Therapy (CBT) CBT provides coping skills, self-monitoring, and goal setting. Regulation of Cues (ROC) Regulation of Cues (ROC) The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.
- Primary Outcome Measures
Name Time Method Attendance Post-Treatment (5 months following baseline) The number of treatment visits attended
Body Mass Index (BMI) as measured by weight and height Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q) Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
Acceptability Post-Treatment (5 months following baseline) Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
Binge Eating as measured by the Eating Disorder Examination (EDE) Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Diagnosis of Binge Eating Disorder (BED) and subclinical BED, number of OBEs (large amount of food and loss of control), objective overeating episodes (large amount of food without loss of control), and SBEs (lack of large amount of food with loss of control) determined by responses to the EDE.
Binge Eating as measured by the Binge Eating Scale (BES) Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
Energy intake Changes from baseline at an average of 20 weeks and 44 weeks Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
- Secondary Outcome Measures
Name Time Method Satiety Responsiveness Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Food Responsiveness Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Reward-Based Eating Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)
Trial Locations
- Locations (1)
UCSD Center for Healthy Eating and Activity Research (CHEAR)
🇺🇸La Jolla, California, United States