NCT06207110Recruiting
Family, Responsibility, Education, Support, and Health for Food Responsiveness
Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 5 Jan 2024
- Start date
- 3 Apr 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- University of California, San Diego
- Diseases
- Obesity
- NCT number
- NCT06207110
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 3 Apr 2024 to the primary completion date, 1 Jan 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child who is taking medication for weight loss
Other illness
- 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
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 7 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC San Diego Center for Healthy Eating and Activity Research (CHEAR) Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Ambulatory Research Center - University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.