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

NCT06207110 | Recruiting DMC

• 2 other identifiers: 8060551R01DK135599
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Food Responsiveness; Satiety Responsiveness; Weight Loss; Overeating

Outcome Measures

Primary Outcomes (3)

• Child age and sex adjusted body mass index z-score (BMIz)

  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

  Change from baseline at 3 months, 6 months, 12 months, and 18 months

• Child percentage of the 95th percentile BMI (%BMIp95)

  Age and Sex specific percentage of the 95th percentile BMI

  Change from baseline 3 months, 6 months, 12 months, and 18 months

• Change in Child Overeating

  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.

  Change from baseline at 6 months,12 months, and 18 months

Secondary Outcomes (16)

• Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire

  Change from baseline at 6 months,12 months, and 18 months]

• Child Food Cue Responsiveness as measured during exposure to a preferred food

  Change from baseline at 6 months,12 months, and 18 months

• Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire

  Change from baseline at 6 months,12 months, and 18 months

• Child Satiety Responsiveness as measured by the Water Load Task (WLT)

  Change from baseline at 6 months,12 months, and 18 months

• Child Inhibition as measured by the Stop Signal Task

  Change from baseline at 6 months,12 months, and 18 months

Study Arms (4)

Regulation of Cues

EXPERIMENTAL

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.

Behavioral: Regulation of Cues

Family-Based Treatment

ACTIVE COMPARATOR

The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.

Behavioral: Family Based Behavioral Treatment

Regulation of Cues +

EXPERIMENTAL

The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake

Behavioral: Regulation of Cues +

Health Education

ACTIVE COMPARATOR

The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Behavioral: Health Education

Interventions

Regulation of Cues + BEHAVIORAL

ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake

Also known as: ROC+

Regulation of Cues +

Family Based Behavioral Treatment BEHAVIORAL

FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.

Also known as: FBT

Family-Based Treatment

Health Education BEHAVIORAL

The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Also known as: HE

Health Education

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed assent and parental consent
• A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
• Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.
• A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level
• Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
• Child is on stable medication regimen for medications that can impact weight (3+ months)
• Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity

You may not qualify if:

• Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
• Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted
• Child who is taking medication for weight loss
• Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
• First degree relative or someone in the household with anorexia or bulimia nervosa.
• Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Minnesota: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92037, United States

RECRUITING

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Related Links

• Learn more on our study webpage

MeSH Terms

Conditions

Pediatric Obesity; Weight Loss; Hyperphagia

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Signs and Symptoms, Digestive

Study Officials

• Kerri Boutelle, Ph.D.

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylen Moline, MPH

CONTACT

1-855-827-3498; chear@ucsd.edu

Kerri Boutelle, Ph.D.

CONTACT

858-249-3528; kboutelle@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kerri Boutelle, Ph.D.,, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)