Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT07804680

Conditions

Autism Spectrum Disorder (ASD)

Cardiometabolic Health Indicators

Cardiometabolic Risk Factors

Metabolic Syndrome

Prediabetes

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to evaluate cardiorespiratory and muscular fitness in children with obesity, with and without autism spectrum disorder (ASD), and examine how fitness relates to body measurements, body composition, and cardiometabolic health. The main questions it aims to answer are:

  • Do children with and without ASD differ in cardiorespiratory fitness and handgrip strength?
  • Are fitness levels related to body composition and measures of cardiometabolic health?

Researchers will compare children with ASD to children without ASD to see if there are differences in fitness, body composition, and cardiometabolic health.

Participants will have information from their medical records reviewed, including:

  • Cardiorespiratory fitness and handgrip strength test results
  • Height, weight, BMI, and body composition measurements
  • Blood test results, including HbA1c and cholesterol levels
  • Age, sex, and other demographic information

Conditions

Autism Spectrum Disorder (ASD)

Cardiometabolic Health Indicators

Cardiometabolic Risk Factors

Metabolic Syndrome

Prediabetes

Study ID

NCT07804680

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pediatric patients 6-18 years of age who received care at the Pediatric Endocrinology Diabetes Prevention and Fitness Clinic between January 1 and December 31, 2026.
  • BMI ≥95th percentile for age and sex, consistent with the definition of pediatric obesity.
  • Documented results from cardiorespiratory fitness testing and/or handgrip strength testing.
  • Documented HbA1c value, when available.
  • Sufficient medical record information to determine ASD status and the primary study outcomes.

Exclusion Criteria:

  • Age <6 or >18 years at the time of clinical assessment.
  • BMI <95th percentile for age and sex.
  • Absence of documented cardiorespiratory fitness or handgrip strength testing.
  • Insufficient medical record information to determine ASD status or primary study outcomes.
  • Duplicate or unusable medical records.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatrics with Autism Spectrum Disorder

Obese and Prediabetic

Pediatrics without Autism Spectrum Disorder

Obese and Pediatric

Primary outcome measure

  • Cardiorespiratory Fitness [ Time Frame: January 1 - December 31 2026 ]
  • Handgrip Strength [ Time Frame: January 1 - December 31 2026 ]
  • Aerobic Capacity [ Time Frame: January 1, 2026 to December 31, 2026 ]

Central Contacts and Locations

Central contacts

Aaron Meadows, MMed

434-924-0395fzj8tx@uvahealth.org

Locations

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Aaron Meadows, MMed

434-924-0395fzj8tx@uvahealth.org

Aaron Meadows, MMed

8592004427erenmedos@gmail.com

Principal Investigator:

Aaron Meadows, MMed

More Information

Sponsor

University of Virginia

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Keywords

  • Cardiorespiratory Fitness
  • Metabolic Syndrome
  • Cardiometabolic Risk Factors
  • Prediabetes
  • Pediatrics
  • Austism Spectrum Disorder
  • Cardiometabolic Health Indicators
  • Fitness Testing
  • Handgrip Strength
  • Muscular Fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-09-04.