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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06207110
Status
Recruiting
Apply to this trial

Conditions

  • Obesity, Childhood

Eligibility Criteria

Sex
ALL
Age
7 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Regulation of Cues — 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 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.
  • Family Based Behavioral Treatment — BEHAVIORAL
    FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
  • Regulation of Cues + — BEHAVIORAL
    ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
  • Health Education — BEHAVIORAL
    The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Study Details

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).

Key Dates

Start date
Apr 3, 2024
Status verified
May 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regulation of Cues
    The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.
  • Active Comparator: Family-Based Treatment
    The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
  • Experimental: Regulation of Cues +
    The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
  • Active Comparator: Health Education
    The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Primary Outcome Measure

Child age and sex adjusted body mass index z-score (BMIz) [ Time Frame: Change from baseline at 3 months, 6 months, 12 months, and 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)La JollaCalifornia92037
Kaylen Moline, MPH
[email protected]
1-855-827-3498
Ambulatory Research Center - University of MinnesotaMinneapolisMinnesota55454
Carol Peterson, Ph.D.
[email protected]
612-273-9811

Find similar trials in La Jolla, CA

By research site
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)· La Jolla, CAAmbulatory Research Center - University of Minnesota· Minneapolis, MN

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