CClinicalTrials.gg
CompletedNCT02328638Updated Jan 20, 2016

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

An interventional study of Parent Education Program and Manual-based Behavioral Treatment in Autism and Obesity, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2016-01-20.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
3 Years to 10 Years
Sex
All
01

Study 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.

Read the detailed description

The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.

02

Conditions studied

  • Autism
  • Obesity

Browse trials for

Keywords

  • ASD
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 10 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Manual-based Behavioral Treatment

    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

  • Placebo comparator
    Parent Education Program

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

    Behavioral: Parent Education Program

Interventions

  • BehavioralParent Education Program

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

    Also known as: PEP

  • BehavioralManual-based Behavioral Treatment

    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.

06

What researchers measure

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.

    Time frame: baseline, post treatment (up to 16 weeks)

Secondary outcomes

  1. Change in intake of healthy food

    The Nutrition arm of the intervention is based on our dietitian's unique ASD-specific adaptations to Best Practices in dietetics and will be supplemented by Children's Healthcare of Atlanta's Strong4Life program.

    Time frame: baseline, post treatment (up to 16 weeks)

  2. Change in physical activity

    The F.I.T.T. Principle will be applied to the physical activity recommendations by identifying the frequency, intensity, time, and type of exercise.

    Time frame: baseline, post treatment (up to 16 weeks)

07

Study locations

1 site
  • Pediatric Feeding Disorders Program at the Marcus Autism Center
    Atlanta, Georgia 30329, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02328638
Lead sponsor
Emory University
Responsible party
Kristen K. Criado (Kristen Criado, Ph.D., Emory University) — Principal investigator
First posted
Dec 31, 2014
Start date
Dec 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Jan 20, 2016

Study contacts

Kristen K Criado, Ph.D.
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion