Solutions for Hunger And Regulating Eating

  • STATUS
    Recruiting
  • End date
    Aug 15, 2026
  • participants needed
    300
  • sponsor
    University of California, San Diego
Updated on 27 September 2021

Summary

The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.

Description

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; 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 BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).

Details
Condition Overweight and Obesity
Treatment Behavioral Weight Loss, Regulation of Cues Enhanced, Nutrition Education, Stress Management and Social Support
Clinical Study IdentifierNCT05004883
SponsorUniversity of California, San Diego
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

high Food Responsiveness
BMI between 25kg/m^2 and 45kg/m^2
able to read English at a 5th grade reading level
willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
able to provide data through questionnaires
has a smart phone through which they can complete Ecological Momentary Assessments

Exclusion Criteria

major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past 3 years)
medical or psychological problems that could make adherence with the study protocol difficult or dangerous
pregnant, lactating, or planning to become pregnant in the next 18 months
participating in other weight control programs and/or taking medication for weight loss
previous bariatric surgery
moving out of the San Diego area for the duration of their study enrollment (18 months)
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