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Open Trial Obesity CHANGE Program ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03047018
Recruitment Status : Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
William Sharp, PhD, Emory University

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 8, 2017
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE October 6, 2017
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Willingness to Participate [ 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.
  • Attendance Rate [ 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.
  • Percent Homework Adherence [ 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%.
  • Percent Demonstration of Skills [ 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%.
  • Attrition Rate [ 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%.
  • Percent Satisfaction [ 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%.
  • Therapist Fidelity to the Treatment Manual [ 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%.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Feasibility measures [ Time Frame: Baseline through Week 36 Follow Up ]
We expect this treatment to be acceptable to families and feasible to implement by meeting the following benchmarks:
  • >70% willingness to participate (<30% refusal from eligible participants)
  • >70% attendance
  • >70% adherence with homework
  • >80% demonstration with skills
  • >85% retention (<15% attrition)
  • >90% satisfaction
  • >80% therapist fidelity to the treatment manual.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Difference in Body Mass Index (BMI) Percentile [ 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.
  • Change in Food Preference Inventory (FPI) Score [ 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.
  • Change in physical activity [ Time Frame: Baseline through Week 36 Follow Up ]
    Physical activity will be measured by parent report and average number of steps by Fitbit data.
  • Change in Parenting Stress Index- Short Form (PSI-SF) Score [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Trial Obesity CHANGE Program ASD
Official Title  ICMJE Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: CHANGE Program
Participants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program.
Intervention: Behavioral: The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
30
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03047018
Other Study ID Numbers  ICMJE IRB00090911
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William Sharp, PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Sharp, PhD Emory University
PRS Account Emory University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP