Solutions for Hunger and Regulating Eating

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-08-15

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Regulation of Cues Enhanced Treatment

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.

Group Type EXPERIMENTAL

Regulation of Cues Enhanced

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss

Intervention Type 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, Stress Management, and Social Support

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

Group Type ACTIVE_COMPARATOR

Nutrition Education, Stress Management and Social Support

Intervention Type BEHAVIORAL

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

Interventions

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Regulation of Cues Enhanced

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.

Intervention Type BEHAVIORAL

Behavioral Weight Loss

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.

Intervention Type BEHAVIORAL

Nutrition Education, Stress Management and Social Support

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

Intervention Type BEHAVIORAL

Other Intervention Names

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ROC+ BWL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kerri Boutelle

Kerri Boutelle, Ph.D., Professor, Herbert Wertheim School of Public Health and Longevity Science and School of Medicine Departments of Pediatrics and Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR