La Jolla, California 92093


Purpose:

The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.


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. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare ROC, BWL, ROC+BWL combined and an active comparator (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.


Criteria:

1. All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45. 2. Participants will provide written informed consent for study participation. 3. Participants will possess English language skills at the 5th grade reading level. 4. Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe. 5. Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires. 6. Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months). 7. Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating. 8. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance. 9. Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included. 10. Participants cannot have a history of bariatric surgery 11. Participants cannot currently be enrolled in an organized weight control program.


NCT ID:

NCT02516839


Primary Contact:

Principal Investigator
Kerri Boutelle, Ph.D.
UCSD

Dawn Eichen, Ph.D.
Phone: 858-534-8322
Email: chear@ucsd.edu


Backup Contact:

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


Location Contact:

La Jolla, California 92093
United States

Kerri Boutelle, PhD
Email: kboutelle@ucsd.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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