Family, Responsibility, Education, Support, and Health for Food Responsiveness
University of California, San Diego · with University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT06207110
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 7–12 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 280
- US sites recruiting
- 2
- Study start
- April 3, 2024
- Record last updated
- May 11, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Regulation of Cues; Family Based Behavioral Treatment; Regulation of Cues +; Health Education
Conditions: Obesity, Childhood
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Recruiting US locations
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, CA 92037
Site contact: Kaylen Moline, MPH · 1-855-827-3498 · chear@health.ucsd.edu
Ambulatory Research Center - University of Minnesota
Minneapolis, MN 55454
Site contact: Carol Peterson, Ph.D. · 612-273-9811 · peter161@umn.edu
Study contacts (from the official record)
- Kaylen Moline, MPH · 1-855-827-3498 · chear@ucsd.edu
- Kerri Boutelle, Ph.D. · 858-249-3528 · kboutelle@ucsd.edu
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