Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity

Study Overview
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Brief Summary
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The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.

Detailed Description
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The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.

Official Title
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Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity

Conditions
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Autism, Obesity

Intervention / Treatment
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* Behavioral: Parent Education Program
* Behavioral: Manual-based Behavioral Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of ASD confirmed by a clinical psychologist using a gold standard diagnostic tools Overweight status, as evidenced by a BMI percentile > 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods Exclusion Criteria: Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications Children with unstable medical conditions will be excluded for safety concerns Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual-based Behavioral Treatment<br>up to 16 weekly behavioral therapy sessions (intervention) following the CHANGE obesity manual, lasting approximately 45 minutes and nutritional therapy sessions, lasting approximately 30 to 60 minutes. | Behavioral: Manual-based Behavioral Treatment<br>* The Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals.<br>|
| Placebo Comparator: Parent Education Program<br>up to 16 weekly behavioral therapy sessions following the parent education program | Behavioral: Parent Education Program<br>* The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.<br>* Other names: PEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index percentile/ratio | Body Mass Index (BMI) is a number calculated from a person's weight divided by height. | baseline, post treatment (up to 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intake of healthy food | The Nutrition arm of the intervention is based on our dietitian's unique ASD-specific adaptations to Best Practices in dietetics and will be supplemented by Children's Healthcare of Atlanta's Strong4Life program. | baseline, post treatment (up to 16 weeks) | 
| Change in physical activity | The F.I.T.T. Principle will be applied to the physical activity recommendations by identifying the frequency, intensity, time, and type of exercise. | baseline, post treatment (up to 16 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD