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

NCT ID: NCT02328638

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Autism; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Manual-based Behavioral Treatment

Intervention Type: 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.

Parent Education Program

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

Group Type: PLACEBO_COMPARATOR

Parent Education Program

Intervention Type: BEHAVIORAL

The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.

Interventions

Parent Education Program

The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PEP

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kristen K. Criado

Kristen Criado, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen K Criado, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Pediatric Feeding Disorders Program at the Marcus Autism Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00073170

Identifier Type: -

Identifier Source: org_study_id