Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
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|ClinicalTrials.gov Identifier: NCT02328638|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autism Obesity||Behavioral: Parent Education Program Behavioral: Manual-based Behavioral Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
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
|United States, Georgia|
|Pediatric Feeding Disorders Program at the Marcus Autism Center|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Kristen K Criado, Ph.D.||Emory University|