Clinical trial NCT03047018: Open Trial Obesity CHANGE Program ASD
Official title: Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Obesity
Keywords: Nutrition
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Willingness to Participate
timeFrame: Baseline through Week 36 Follow Up
measure: Attendance Rate
timeFrame: Baseline through Week 36 Follow Up
measure: Percent Homework Adherence
timeFrame: Baseline through Week 36 Follow Up
measure: Percent Demonstration of Skills
timeFrame: Baseline through Week 36 Follow Up
measure: Attrition Rate
timeFrame: Baseline through Week 36 Follow Up
measure: Percent Satisfaction
timeFrame: Baseline through Week 36 Follow Up
measure: Therapist Fidelity to the Treatment Manual
timeFrame: Baseline through Week 36 Follow Up
Secondary outcomes:
measure: Difference in Body Mass Index (BMI) Percentile
timeFrame: Baseline through Week 36 Follow Up
measure: Change in Food Preference Inventory (FPI) Score
timeFrame: Baseline through Week 36 Follow Up
measure: Change in physical activity
timeFrame: Baseline through Week 36 Follow Up
measure: Change in Parenting Stress Index- Short Form (PSI-SF) Score
timeFrame: Baseline through Week 36 Follow Up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: William Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References: