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

Emory University

Status: Completed

Conditions: Obesity; Autism

Treatments: Behavioral: Parent Education Program; Behavioral: Manual-based Behavioral Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02328638

IRB00073170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Manual-based Behavioral Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Manual-based Behavioral Treatment

Parent Education Program

Placebo Comparator group

Description:

up to 16 weekly behavioral therapy sessions following the parent education program

Treatment:

Behavioral: Parent Education Program