Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Study Overview
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Brief Summary
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A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.

Official Title
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Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
* Behavioral: Education plus usual care behavioral treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate Exclusion Criteria: Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone Conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason Conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language Unable to read, understand or complete informed consent in English or Spanish

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wise interventions plus behavioral Rx<br>Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control. | Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment<br>* Addition 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<br>|
| Active Comparator: Education plus behavioral Rx<br>Health education plus a usual care behavioral intervention for weight control | Behavioral: Education plus usual care behavioral treatment<br>* 6-month health education plus usual care behavioral intervention for weight control in children with obesity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index From Baseline to 6 Months | body mass index = weight in kilograms divided by the squared height in meters | Change from baseline to 6 months |