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Family, Responsibility, Education, Support, and Health for Food Responsiveness
RECRUITINGN/ASponsored by University of California, San Diego
Actively Recruiting
PhaseN/A
SponsorUniversity of California, San Diego
Started2024-04-03
Est. completion2029-01-01
Eligibility
Age7 Years – 12 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06207110
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).
Eligibility
Age: 7 Years – 12 YearsHealthy volunteers accepted
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.
Conditions2
Obesity, ChildhoodWeight Loss
Locations2 sites
California
1 siteUC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
Minnesota
1 siteAmbulatory Research Center - University of Minnesota
Minneapolis, Minnesota, 55454
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Actively Recruiting
PhaseN/A
SponsorUniversity of California, San Diego
Started2024-04-03
Est. completion2029-01-01
Eligibility
Age7 Years – 12 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06207110