Solutions for Hunger And Regulating Eating

Running, not enrolling · Not applicable

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT05004883

Run by

University of California, San Diego

People needed

300

Starts

2021-09-01

Expected to finish

2026-08-15

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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