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Open Trial Obesity CHANGE Program ASD

Primary Purpose

Autism Spectrum Disorder, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Nutrition

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CHANGE Program

Arm Description

Participants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program.

Outcomes

Primary Outcome Measures

Willingness to Participate

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

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

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

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

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

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

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%.

Secondary Outcome Measures

Difference in Body Mass Index (BMI) Percentile

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

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

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

The PSI-SF is a 36-item survey commonly used measure parental stress. A higher score indicates more parental stress.

Full Information

NCT ID

NCT03047018

First Posted

February 7, 2017

Last Updated

December 2, 2020

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT03047018

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 6, 2017 (Actual)

Primary Completion Date

March 20, 2020 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Obesity

Keywords

Nutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHANGE Program

Arm Type

Experimental

Arm Description

Participants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program.

Intervention Type

Behavioral

Intervention Name(s)

The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Willingness to Participate

Description

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

Title

Attendance Rate

Description

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

Title

Percent Homework Adherence

Description

Time Frame

Baseline through Week 36 Follow Up

Title

Percent Demonstration of Skills

Description

Time Frame

Baseline through Week 36 Follow Up

Title

Attrition Rate

Description

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

Title

Percent Satisfaction

Description

Time Frame

Baseline through Week 36 Follow Up

Title

Therapist Fidelity to the Treatment Manual

Description

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

Secondary Outcome Measure Information:

Title

Difference in Body Mass Index (BMI) Percentile

Description

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

Title

Change in Food Preference Inventory (FPI) Score

Description

Time Frame

Baseline through Week 36 Follow Up

Title

Change in physical activity

Description

Physical activity will be measured by parent report and average number of steps by Fitbit data.

Time Frame

Baseline through Week 36 Follow Up

Title

Change in Parenting Stress Index- Short Form (PSI-SF) Score

Description

The PSI-SF is a 36-item survey commonly used measure parental stress. A higher score indicates more parental stress.

Time Frame

Baseline through Week 36 Follow Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Sharp, PhD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Open Trial Obesity CHANGE Program ASD

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