Status:
RECRUITING
Family, Responsibility, Education, Support, and Health for Food Responsiveness
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity, Childhood
Eligibility:
All Genders
7-12 years
Phase:
NA
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 ...
Detailed Description
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06207110
Start Date
April 3 2024
End Date
January 1 2029
Last Update
May 11 2025
Active Locations (2)
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1
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States, 92037
2
Ambulatory Research Center - University of Minnesota
Minneapolis, Minnesota, United States, 55454