Solutions for Hunger And Regulating Eating

NCT05004883 | Active Not Recruiting DMC

• 2 other identifiers: 201362R01DK122504
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Keywords

Food Responsiveness; Satiety Responsiveness; Weight Loss; Overeating

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index

  Body Mass Index as measured by height and weight

  Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months

Secondary Outcomes (6)

• Change in Food Responsiveness As Measured by the FR Scale of the AEBQ

  Change from baseline at an average of 6 months, 12 months, and 18 months

• Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ

  Change from baseline at an average of 6 months, 12 months, and 18 months

• Change in Inhibition As Measured by the Stop Signal Task

  Change from baseline at an average of 6 months, 12 months, and 18 months

• Change in Restriction As Measured by the TFEQ

  Change from baseline at an average of 6 months, 12 months, and 18 months

• Change in Caloric Intake As Measured by the DHQ III

  Change from baseline at an average of 6 months, 12 months, and 18 months

Study Arms (3)

Regulation of Cues Enhanced Treatment

EXPERIMENTAL

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.

Behavioral: Regulation of Cues Enhanced

Behavioral Weight Loss

ACTIVE COMPARATOR

The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Behavioral: Behavioral Weight Loss

Nutrition, Stress Management, and Social Support

ACTIVE COMPARATOR

Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.

Behavioral: Nutrition Education, Stress Management and Social Support

Interventions

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.

Also known as: ROC+

Regulation of Cues Enhanced Treatment

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.

Also known as: BWL

Behavioral 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.

Nutrition, Stress Management, and Social Support

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Minnesota: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Boutelle KN, Eichen DM, Obayashi S, Pasquale EK, Strong DR, Tietz AS, Reed KL, Peterson CB. Design of the SHARE study: A randomized controlled trial evaluating the regulation of cues treatment for adults with overweight or obesity and high food responsiveness. Contemp Clin Trials. 2025 Aug;155:107970. doi: 10.1016/j.cct.2025.107970. Epub 2025 Jun 1.

  PMID: 40460908 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Hyperphagia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Kerri Boutelle, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kerri Boutelle, Ph.D., Professor, Herbert Wertheim School of Public Health and Longevity Science and School of Medicine Departments of Pediatrics and Psychiatry

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)