Clincosm LogoSign in Get a demo

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

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT02328638
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
8
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent Education Program
  • Behavioral: Manual-based Behavioral Treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.
Placebo Comparator: Parent Education Program

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

Behavioral: Parent Education Program
The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.
Other Names:
  • PEP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in body mass index percentile/ratio [baseline, post treatment (up to 16 weeks)]

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

    Secondary Outcome Measures

    1. Change in intake of healthy food [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric Feeding Disorders Program at the Marcus Autism Center Atlanta Georgia United States 30329

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Kristen K Criado, Ph.D., Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristen K. Criado, Kristen Criado, Ph.D., Emory University
    ClinicalTrials.gov Identifier:
    NCT02328638
    Other Study ID Numbers:
    • IRB00073170
    First Posted:
    Dec 31, 2014
    Last Update Posted:
    Jan 20, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Kristen K. Criado, Kristen Criado, Ph.D., Emory University
    ASD
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Jan 20, 2016