Clinical trial

Solutions for Hunger And Regulating Eating

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05004883

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight and Obesity

Full registry criteria

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)

Treatments and study arms

Regulation of Cues Enhanced

Behavioral

ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to treat high Food Responsiveness and low Satiety Responsiveness. BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure exercises.

Behavioral Weight Loss

Behavioral

The BWL program includes dietary, physical activity, and behavioral change recommendations. All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories, and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.

Nutrition Education, Stress Management and Social Support

Behavioral

Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

Primary outcomes

Change in Body Mass IndexChange from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months

Body Mass Index as measured by height and weight

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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