Emory University
Atlanta, Georgia, 30308, United States
NCT Number: NCT03047018
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.
Looking for future studies?
Notify Me5 year–12 year
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30308, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline through Week 36 Follow Up
Willingness to participate is measured as <30% refusal of study participation from eligible participants. Willingness to participate will be used to measure overall study feasibility.
Time frame: Baseline through Week 36 Follow Up
The number of participants who attend all study visits. The attendance rate will be used to measure overall study feasibility. A successful attendance rate will be measured as >70% attendance.
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who complete all homework assignments. Percent homework adherence will be used to measure overall study feasibility. A successful adherence percentage will be measured as >70%.
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who demonstrate skills learned through the CHANGE program. Percent demonstration of skills will be used to measure overall study feasibility. A successful percentage will be measured as >80%.
Time frame: Baseline through Week 36 Follow Up
The number of participants who do not complete all study visits. The attrition rate will be used to measure study feasibility. An acceptable attrition rate will be considered <15%.
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who report being satisfied with the intervention. Percent satisfaction will be used to measure overall study feasibility. A successful percentage will be measured as >90%.
Time frame: Baseline through Week 36 Follow Up
The percentage of therapists who adhere to the treatment manual. Therapist fidelity will be used to measure overall study feasibility. A successful percentage rate is >80%.
Time frame: Baseline through Week 36 Follow Up
The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height.
Time frame: Baseline through Week 36 Follow Up
The FPI is a 154-item, parent-reported measure of food selectivity. This measure provides important information about which foods the child eats across food groups. A food selectivity score is calculated by dividing the number of foods rated "never" by the total number of foods listed.
Time frame: Baseline through Week 36 Follow Up
Physical activity will be measured by parent report and average number of steps by Fitbit data.
Time frame: Baseline through Week 36 Follow Up
The PSI-SF is a 36-item survey commonly used measure parental stress. A higher score indicates more parental stress.
Emory University
Other
Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07514910
Autism Spectrum Disorder, Autistic Disorder
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05741840
Autism, Autism Spectrum Disorder
La Jolla, California, United States
View Trial DetailsNCT06352372
Autism Spectrum Disorder, Autistic Disorder
Phoenix, Arizona, United States
View Trial DetailsNCT07277101
Autism Spectrum Disorder, Autistic Disorder
Shanghai, China
View Trial Details