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La Jolla, California 92093


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).

Study summary:

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.


Inclusion Criteria: 1. All participants will be Veteran or civilian men and women between the ages of 18-65 meeting criteria for overweight, with a 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 taking medication that may impair physical activity tolerance or performance (e.g., beta blockers) 11. Participants will not be participating in group or individual psychotherapy for binge eating or weight management. 12. 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 Contact:

Principal Investigator
Kerri Boutelle, Ph.D

Saori Obayashi, Ph.D
Phone: 858-246-2879
Email: sobayashi@ucsd.edu

Backup Contact:

Email: kboutelle@ucsd.edu
Kerri Boutelle, P.D
Phone: 858-534-8037

Location Contact:

La Jolla, California 92093
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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