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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328638
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Kristen K. Criado, Emory University

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
Autism Obesity Behavioral: Parent Education Program Behavioral: Manual-based Behavioral Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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 Name: PEP




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328638


Locations
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United States, Georgia
Pediatric Feeding Disorders Program at the Marcus Autism Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Kristen K Criado, Ph.D. Emory University
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Responsible Party: Kristen K. Criado, Kristen Criado, Ph.D., Emory University
ClinicalTrials.gov Identifier: NCT02328638    
Other Study ID Numbers: IRB00073170
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Kristen K. Criado, Emory University:
ASD
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight