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

Not Applicable

Completed

• Conditions: Autism; Obesity
• Interventions: Behavioral: Manual-based Behavioral Treatment; Behavioral: Parent Education Program

• Registration Number: NCT02328638
• Lead Sponsor: Emory University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-31
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual-based Behavioral Treatment	Manual-based Behavioral Treatment	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	Parent Education Program	up to 16 weekly behavioral therapy sessions following the parent education program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in physical activity	baseline, post treatment (up to 16 weeks)	The F.I.T.T. Principle will be applied to the physical activity recommendations by identifying the frequency, intensity, time, and type of exercise.
Change in intake of healthy food	baseline, post treatment (up to 16 weeks)	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.

Trial Locations

Locations (1)

Pediatric Feeding Disorders Program at the Marcus Autism Center; 🇺🇸 Atlanta, Georgia, United States