Open Trial Obesity CHANGE Program ASD
Condition: Autism Spectrum Disorder; Obesity
MeSH terms: Obesity; Autism Spectrum Disorder
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
Intervention type(s): Behavioral
Intervention description(s): The CHANGE program is a 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. Nutrition intervention focuses on decreasing excess calories from liquids and solids and creating a balanced meal plan. Physical activity intervention uses fading strategies to increase participation in exercise. Behavior strategies promote success with meeting goals. Problem-solving techniques address challenges to adherence with implementing the program in the home setting. The standardized protocols include educational handouts, clinic-based activities and assessment procedures, and caregiver-directed homework and data collection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutrition