NCT05004883

Solutions for Hunger and Regulating Eating

Targeting Food Cue Responsiveness for Weight Loss

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Overweight and Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-08-15
• Completion: 2026-08-15
• First posted: 2021-08-13
• Last updated: 2024-09-03

Locations

1 site across 1 country: United States