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Search / Trial NCT06207110

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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jan 5, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Food Responsiveness Satiety Responsiveness Weight Loss Overeating

ClinConnect Summary

This clinical trial is studying different ways to help children aged 7 to 12 who are overweight or obese and have a strong desire for food, known as food responsiveness. Researchers want to compare several approaches, including a program that helps families understand and manage food cues, a family-based treatment that focuses on support and guidance, a combined program that offers nutrition education and helps reduce calorie intake, and a general health education program. The goal is to see which method is most effective in promoting healthier eating habits and managing weight in these children.

To participate, children must be between 7 and 12 years old, have a body weight that falls into the overweight or obese range, and show high food responsiveness, which will be measured through a specific scale. Parents who prepare food at home must also be involved and capable of understanding the program. Families need to be committed to attending all sessions and participating fully. It's important to note that children with certain medical or psychological conditions, as well as parents facing significant mental health challenges, are not eligible to join the study. Participants can expect to engage in various activities and receive support throughout the trial, which aims to create a healthier environment for both the child and their family.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Informed assent and parental consent
  • 2. A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
  • 3. 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.
  • 4. 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
  • 5. Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
  • 6. Child is on stable medication regimen for medications that can impact weight (3+ months)
  • 7. 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
  • Exclusion Criteria:
  • 1. Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
  • 2. 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
  • 3. Child who is taking medication for weight loss
  • 4. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
  • 5. 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.

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

Minneapolis, Minnesota, United States

La Jolla, California, United States

Patients applied

0 patients applied

Trial Officials

Kerri Boutelle, Ph.D.

Principal Investigator

UC San Diego

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported