NCT07804680 · University of Virginia
This Study Will Evaluate Cardiorespiratory and Muscular Fitness to Examine Associations With Anthropometric Characteristics and Other Indicators of Cardiometabolic Risk Among Patients With or Without Autism Spectrum Disorder
(ROACH)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Cardiorespiratory Fitness
Time frame: January 1 - December 31 2026
Cardiorespiratory Fitness as determined by 3-minute step test results, which includes post 1-minute heartrate per Kasch Pulse Recovery Test
Handgrip Strength
Time frame: January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
Aerobic Capacity
Time frame: January 1, 2026 to December 31, 2026
Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations