Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2017-10-06
2020-03-20
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CHANGE Program
Participants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program.
The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
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.
Interventions
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The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
12 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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William Sharp, PhD
Associate Professor
Principal Investigators
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William Sharp, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00090911
Identifier Type: -
Identifier Source: org_study_id