Solutions for Hunger And Regulating Eating (NCT05004883) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Solutions for Hunger And Regulating Eating
United States300 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Change in Body Mass Index
Timeframe: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months