Open Trial Obesity CHANGE Program ASD
Completed · Not applicable
Conditions studied: Autism Spectrum Disorder, Obesity
In brief
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program. Twenty children with autism spectrum disorder (ASD) who are also overweight will participate in this study at the Marcus Autism Center. All children who enroll will receive the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. This involves 16 sessions over six months. After the six months, participants will come back every month for three months for a follow up visit. Therefore the study will last a total of nine months.
Key facts
- Study ID
- NCT03047018
- Run by
- Emory University
- People needed
- 35
- Starts
- 2017-10-06
- Expected to finish
- 2020-03-20
- Last updated by the study team
- 2020-12-04
Who can join
Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with ASD using DSM-5 criteria, and clinically significant SCQ score.
- Children with mild to moderate food selectivity, as reflected by a) a diet involving at least 6 food items, b) accepting at least one fruit or vegetable as measured by the Food Preference Inventory (FPI), and c) engaging in low mealtime behavior problems on Brief Autism Mealtime Behavior Inventory (BAMBI) Food Refusal subscale
- Child with a clinic-confirmed body mass index (BMI) percentile in the obese range (i.e., > 95th percentile)
- Parent (primary caregiver) who agrees to participate and attend treatment sessions
- Participating parent able to speak, understand, read, and write in English (assessments, curriculum materials and instructions are in English)
You may not qualify if…
- Children with severe feeding problems (e.g., < 5 preferred foods as measured by the FPI) or complex medical issues (e.g., gastrostomy-tube or formula dependent) who require a different treatment approach
- Children on medication associated with weight gain in ASD (e.g., risperidone) that has not yet stabilized (stability criteria defined as 6 months or longer i.e. child has been on medication for less than 6 months).
- Children with serious behavioral problems (i.e., aggression, tantrums, self-injury) or another psychiatric condition that requires a different treatment approach.
- Children with unstable medical conditions or those with a known associated with weight problems will not be included in this study.
Where it is running
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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