About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Medical conditions affecting growth
Medications affecting growth
Conditions limiting participation in the interventions
Conditions limiting participation in the assessments
Trial design
Parallel
Treatments tested in this trial
Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
BehavioralAddition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity
Education plus usual care behavioral treatment
Behavioral6-month health education plus usual care behavioral intervention for weight control in children with obesity
Treatment groups
Trial outcomes
Primary outcomes
Change in body mass index from baseline to 12 months
body mass index = weight in kilograms divided by the squared height in meters
Sponsors and contacts
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Stanford University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator