Open Trial Obesity CHANGE Program ASD

NCT03047018 | Completed

• 1 other identifier: IRB00090911
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Obesity

Keywords

Nutrition

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline through Week 36 Follow Up

• 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.

  Baseline through Week 36 Follow Up

• 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%.

  Baseline through Week 36 Follow Up

• 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%.

  Baseline through Week 36 Follow Up

• 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%.

  Baseline through Week 36 Follow Up

• 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%.

  Baseline through Week 36 Follow Up

• 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%.

  Baseline through Week 36 Follow Up

Secondary Outcomes (4)

• Difference in Body Mass Index (BMI) Percentile

  Baseline through Week 36 Follow Up

• Change in Food Preference Inventory (FPI) Score

  Baseline through Week 36 Follow Up

• Change in physical activity

  Baseline through Week 36 Follow Up

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

  Baseline through Week 36 Follow Up

Study Arms (1)

CHANGE Program

EXPERIMENTAL

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

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

Interventions

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

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.

CHANGE Program

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Obesity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Sharp, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 8, 2017
• Study Start: October 6, 2017
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)