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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual-based Behavioral Treatment | Active Comparator | 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. |
|
| Parent Education Program | Placebo Comparator | up to 16 weekly behavioral therapy sessions following the parent education program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Education Program | Behavioral | The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen K Criado, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Feeding Disorders Program at the Marcus Autism Center | Atlanta | Georgia | 30329 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Manual-based Behavioral Treatment | Behavioral | 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. |
|
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) |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |