Family, Responsibility, Education, Support, and Health for Food Responsiveness (NCT06207110) | Clinical Trial Compass
RecruitingNot Applicable
Family, Responsibility, Education, Support, and Health for Food Responsiveness
United States280 participantsStarted 2024-04-03
Plain-language 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).
Who can participate
Age range7 Years – 12 Years
SexALL
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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
✕. 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
What they're measuring
1
Child age and sex adjusted body mass index z-score (BMIz)
Timeframe: Change from baseline at 3 months, 6 months, 12 months, and 18 months
2
Child percentage of the 95th percentile BMI (%BMIp95)
Timeframe: Change from baseline 3 months, 6 months, 12 months, and 18 months
3
Change in Child Overeating
Timeframe: Change from baseline at 6 months,12 months, and 18 months