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Open Trial Obesity CHANGE Program ASD

NCT03047018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-12-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • William Sharp, PhD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047018 on ClinicalTrials.gov