Summary

for people ages 18-65 (full criteria)
at La Jolla, California
study started
estimated completion:
Kerri Boutelle

Description

Summary

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.

Official Title

Treatment of Obesity Targeting Appetite and Cue Reactivity

Details

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.

Keywords

Overweight Obesity Overeating Body Mass Index Weight Treatment Cravings Intervention Behavioral Treatment Regulation of Cues (ROC) Behavioral Weight Loss (BWL) BWL + ROC Nutrition Education, Stress Management and Social Support BWL+ ROC Nutrition Education, Stress Management Social Support

Eligibility

For people ages 18-65

  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.

Location

  • UCSD Center for Healthy Eating and Activity Research (CHEAR)
    La Jolla California 92093 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02516839
Lead Scientist
Kerri Boutelle
Study Type
Interventional
Last Updated
November 17, 2017