Clinical trial NCT03678766: CHARGE: Controlling Hunger and ReGulating Eating
Official title: Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Overweight
Obesity
Keywords: Overweight
Obesity
Binge Eating
Overeating
Body Mass Index
Weight
Treatment
Intervention
Behavioral Treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
name: United States Department of Defense
First posted: 2018-09-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
2. Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
3. Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
4. Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
5. Participants will be willing to maintain contact with the investigators for 11 months.
6. 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.
7. 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.
8. Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
9. Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
10. Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
11. Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.

Primary outcomes:
measure: Attendance
timeFrame: Post-Treatment (5 months following baseline)
measure: Acceptability
timeFrame: Post-Treatment (5 months following baseline)
measure: Binge Eating as measured by the Eating Disorder Examination (EDE)
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Binge Eating as measured by the Binge Eating Scale (BES)
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q)
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Body Mass Index (BMI) as measured by weight and height
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Energy intake
timeFrame: Changes from baseline at an average of 20 weeks and 44 weeks
Secondary outcomes:
measure: Satiety Responsiveness
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Food Responsiveness
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
measure: Reward-Based Eating
timeFrame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
citation: Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.