NCT06207110

Family, Responsibility, Education, Support, and Health for Food Responsiveness

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).

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 FBT has merit for some children, but not all, this study will compare ROC to FBT, ROC with nutrition education and reducing energy intake (ROC+), and Health Education (HE). Treatment will consist of weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months for a total of 20 sessions. The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness (FR) and their parent and will conduct assessments at baseline, post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18).

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
BEHAVIORAL	Regulation of Cues	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 improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.
BEHAVIORAL	Family Based Behavioral Treatment	FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
BEHAVIORAL	Regulation of Cues +	ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
BEHAVIORAL	Health Education	The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Timeline

• Start date: 2024-04-03
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-01-16
• Last updated: 2025-05-11

Locations

2 sites across 1 country: United States