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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02328638
Enrollment
10
Registered
2014-12-31
Start date
2014-12-31
Completion date
2015-08-31
Last updated
2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Obesity

Keywords

ASD

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.

Interventions

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

BEHAVIORALManual-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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in intake of healthy foodbaseline, 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.
Change in physical activitybaseline, 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026