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Active (not recruiting) Not applicable NCT05004883

Solutions for Hunger And Regulating Eating

No applicable phase (e.g. observational)
Conditions: Overweight and Obesity

Sponsor: University of California, San Diego

trial.available_in: БГ
Overview
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).
Who can participate
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 year) * 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)
Interventions
Regulation of Cues Enhanced
BEHAVIORAL
Behavioral Weight Loss
BEHAVIORAL
Nutrition Education, Stress Management and Social Support
BEHAVIORAL
Locations 1
United States (1)
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla , California
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.09.2021
Completion date
15.08.2026
Registry ID
NCT05004883
Source
clinicaltrials.gov
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