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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328638
• Other study ID #: IRB00073170
• Status: Completed
• Phase: N/A
• First received: December 23, 2014
• Last updated: January 19, 2016
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Obesity

Intervention

Behavioral:
• Parent Education Program
The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.
• Manual-based Behavioral Treatment
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.

Locations

Country	Name	City	State
United States	Pediatric Feeding Disorders Program at the Marcus Autism Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No