Study for Childhood Obesity and Food Responsiveness

This study is looking for children aged 7-12 who are overweight or have obesity and tend to overeat due to how they respond to food (high food responsiveness). It compares four different approaches to help manage weight: Regulation of Cues (ROC), Family Based Behavioral Treatment (FBT), ROC with added nutrition education (ROC+), and a general Health Education program. The goal is to see which approach best helps children improve their body mass index (BMIz), percentage of the 95th percentile BMI (%BMIp95), and reduce overeating over 18 months. You or your child would need to be between 7 and 12 years old, have overweight or obesity, and score 3.8 or higher on the Food Responsiveness Scale.

Study design
This interventional study plans to enroll 280 participants. It compares four different behavioral interventions.
What's involved
Participants will have weekly individual sessions for the first 16 weeks, then twice a month for the next 2 months, totaling 20 sessions. Assessments will be done at the start, after treatment (6 months), and at 6-month and 12-month follow-ups.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment, with assessments at 6 months and 12 months post-treatment.

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NCT06207110

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

Recruiting
NAAges 7–12InterventionalTreatment
University of California, San Diego
~280 participants
Updated 2025-05-11 on ClinicalTrials.gov
What's tested:Regulation of CuesFamily Based Behavioral TreatmentRegulation of Cues +Health Education

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Child age and sex adjusted body mass index z-score (BMIz)
Measured over Change from baseline at 3 months, 6 months, 12 months, and 18 months
+2 more outcomes measured
Obesity, Childhood
2 sites across 2 states
California1
Minnesota1
  • Kerri Boutelle, Ph.D. · PRINCIPAL_INVESTIGATOR · UC San Diego

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

    Age and sex adjusted body mass index (BMI (kg/m\^2)) z-score based on the Centers for for Disease Control and Prevention (CDC) norms

  • Child percentage of the 95th percentile BMI (%BMIp95)Change from baseline 3 months, 6 months, 12 months, and 18 months

    Age and Sex specific percentage of the 95th percentile BMI

  • Change in Child OvereatingChange from baseline at 6 months,12 months, and 18 months

    Measured by The Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.