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OpenTrials
Completed

NCT Number: NCT02328638

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Feeding Disorders Program at the Marcus Autism Center

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent Education Program

Behavioral

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

Other names: PEP

Manual-based Behavioral Treatment

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.

Primary outcomes

  1. Change in body mass index percentile/ratio

    Time frame: baseline, post treatment (up to 16 weeks)

    Body Mass Index (BMI) is a number calculated from a person's weight divided by height.

Secondary outcomes

  1. Change in intake of healthy food

    Time frame: 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.

  2. Change in physical activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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