Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity

NCT02328638 | Completed

• 1 other identifier: IRB00073170
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.

Conditions

Autism; Obesity

Keywords

ASD

Outcome Measures

Primary Outcomes (1)

• Change in body mass index percentile/ratio

  Body Mass Index (BMI) is a number calculated from a person's weight divided by height.

  baseline, post treatment (up to 16 weeks)

Secondary Outcomes (2)

• Change in intake of healthy food

  baseline, post treatment (up to 16 weeks)

• Change in physical activity

  baseline, post treatment (up to 16 weeks)

Study Arms (2)

Manual-based Behavioral Treatment

ACTIVE COMPARATOR

up to 16 weekly behavioral therapy sessions (intervention) following the CHANGE obesity manual, lasting approximately 45 minutes and nutritional therapy sessions, lasting approximately 30 to 60 minutes.

Behavioral: Manual-based Behavioral Treatment

Parent Education Program

PLACEBO COMPARATOR

up to 16 weekly behavioral therapy sessions following the parent education program

Behavioral: Parent Education Program

Interventions

Parent Education Program BEHAVIORAL

The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.

Also known as: PEP

Parent Education Program

Manual-based Behavioral Treatment BEHAVIORAL

The Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals.

Manual-based Behavioral Treatment

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
• Overweight status, as evidenced by a BMI percentile \> 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods

You may not qualify if:

• Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
• Children with unstable medical conditions will be excluded for safety concerns
• Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Pediatric Feeding Disorders Program at the Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Obesity

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; 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

• Kristen K Criado, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Criado, Ph.D.

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)