Solutions for Hunger And Regulating Eating

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

Interventions

BEHAVIORAL

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.

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.

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.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Kerri Boutelle, Ph.D. · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2026-08-15

Completion

2026-08-15

Countries

• United States

Study Locations