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

NCT06207110 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-05-11

No results posted yet for this study

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).

Conditions

  • Obesity, Childhood

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kerri Boutelle, Ph.D. · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06207110 on ClinicalTrials.gov