Open Trial Obesity CHANGE Program ASD

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.

The optional sub-study will focus on assessing the gut microbiome. The goal will be to
determine if there any identifiable factors in the gut microbiome which may be associated
with obesity or changes in weight throughout the study. Participants will provide a stool
sample collected on two separate swabs that will be stored in a freezer. All samples will be
analyzed at the end of the study. Participation in this study is optional and will in no way
affect participation in the primary study.

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.