Open Trial Obesity CHANGE Program ASD

Obesity Clinical Trial

Official title: Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Obesity

• NCT number: NCT03047018
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Completion date: March 20, 2020