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Recruiting
NCT07839832
Stanford Healthy Goals Study
Conditions: Obesity, Childhood
Sex: All
Ages: 10 Years – 15 Years
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Stanford University
Location: Stanford University Stanford California
Summary
Past modest, transient and highly variable outcomes from many behavioral treatments for pediatric obesity may be, in part, because of the psychological barriers children with obesity face when trying to control their weight. The goal of this randomized controlled trial is to test whether adding two innovative, brief, social psychological activities (termed "wise" interventions) to a high quality, family-based, group behavioral weight control program, will produce better outcomes among participating children with obesity.
The primary hypothesis is that children who receive the family-based, group, behavioral weight control program plus the wise social psychological interventions will have significantly less body mass index growth over 12 months than children who receive the family-based, group, behavioral weight control program plus additional educational content.
Participants will be asked to do participate in the six month treatment program and complete measurements at the beginning of the study, after 3 months, after 6 months (the end of the behavioral treatment program), and after 12 months (6 months after completing the behavioral treatment program).
This study has the potential to substantially improve the outcomes of pediatric weight control treatments and significantly reduce concurrent and future health, psychological and social harms from childhood obesity.
Eligibility Criteria
Inclusion Criteria:
* 10-15 year old children
* Obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization.
* Child and at least one parent/guardian must agree to participate
Exclusion Criteria:
* Medical conditions affecting growth
* Medications affecting growth
* Conditions limiting participation in the interventions
* Conditions limiting participation in the assessments
* Unable to read, understand or complete informed consent in English or Spanish
* Other exclusion as deemed by the investigators
Source: ClinicalTrials.gov (NCT07839832). StuddyBuddy aggregates publicly available trial information.