Open Trial Obesity CHANGE Program ASD

Emory University

Status

Completed

Conditions

Autism Spectrum Disorder

Obesity

Treatments

Behavioral: The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program

Study type

Interventional

Funder types

Other

Identifiers

NCT03047018

IRB00090911

Details and patient eligibility

About

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.

Full description

This is a 24-week, open trial pilot of 20 children (ages 5 to 12 years old) with ASD and obesity. Subjects will be enrolled in the CHANGE program, a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. After 24 weeks, subjects will be asked to return for follow up assessments at 1, 2 and 3 months later.

The primary aims of this project are to 1) determine the feasibility of the intervention, 2) examine preliminary efficacy, and 3) obtain feedback from parents to improve the effectiveness of the intervention and fit for families.

Enrollment

35 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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.