UVA Health
Charlottesville, Virginia, 22903, United States
Location status: Recruiting
Location contact
Aaron Meadows, MMed
CONTACT
Aaron Meadows, MMed
CONTACT
Aaron Meadows, MMed
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07804680
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
Interested in participating?
Request Info6 year–18 year
All sexes
Observational
Charlottesville, Virginia, 22903, United States
Location status: Recruiting
Aaron Meadows, MMed
CONTACT
Aaron Meadows, MMed
CONTACT
Aaron Meadows, MMed
PRINCIPAL_INVESTIGATOR
Pediatric obesity and cardiometabolic health problems are major public health concerns. Children with obesity may have a higher risk of developing conditions such as insulin resistance, prediabetes, abnormal cholesterol levels, high blood pressure, and cardiovascular disease later in life. In clinical practice, body mass index (BMI), body measurements, and blood tests are commonly used to assess health risk. Although these measures provide important information, they do not fully describe how well a child's heart, lungs, and muscles work during physical activity. Cardiorespiratory fitness (CRF) provides information about the body's ability to use oxygen during exercise and reflects the combined function of several body systems. Higher levels of CRF have been associated with better cardiometabolic health and a lower risk of future disease.
Fitness testing is not routinely used in pediatric clinical settings. Traditional CRF testing may require specialized equipment and exercise at maximal intensity, which can be difficult for some children and may not be practical during a routine clinic visit. Simple, clinically feasible tests, such as the 3-minute step test (3MST), may provide a practical way to assess cardiorespiratory fitness without requiring expensive equipment or maximal exercise. Handgrip strength (HGS) testing is another simple measure that can provide information about muscular fitness and physical function. These tests may be especially useful in pediatric populations because they can be completed in a relatively short period of time and require limited equipment.
Research has shown that cardiorespiratory and muscular fitness are related to several measures of cardiometabolic health, including body composition, blood glucose, cholesterol levels, and other risk factors for metabolic and cardiovascular disease. However, less is known about how these fitness measures relate to cardiometabolic health in children with obesity who are evaluated in routine clinical care, particularly among children with autism spectrum disorder (ASD). Children with ASD may have differences in physical activity, motor skills, and participation in exercise that could affect fitness and cardiometabolic health.
This study will examine cardiorespiratory and muscular fitness in children with obesity, with and without ASD. The study will evaluate whether differences in fitness are associated with body measurements, body composition, and markers of cardiometabolic health, including blood glucose and lipid measures. The findings may improve understanding of the relationship between physical fitness and cardiometabolic health in children with obesity and may help determine whether simple fitness assessments can provide useful information during pediatric clinical evaluations. In the future, these assessments may support more individualized exercise recommendations and contribute to strategies for improving long-term cardiometabolic health in children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
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
Time frame: January 1 - December 31 2026
As defined by HbA1c levels
Time frame: January 1 - December 31 2026
As defined by blood pressure
Time frame: January 1 - December 31 2026
As defined by BMI percentile > 95th percentile
Time frame: January 1 - December 31 2026
As determined by level of low-density lipoprotein
Time frame: January 1 - December 31 2026
As defined by high-density lipoprotein levels
Time frame: January 1 - December 31 2026
As defined by levels of Triglycerides
Time frame: January 1 - December 31 2026
As defined by level of total cholesterol
Time frame: January 1 - December 31 2026
As defined by resting heart rate in beats per minute
Contact information is provided by the study sponsor or research team.
University of Virginia
Other
Cardiorespiratory Fitness, Handgrip Strength, and Cardiometabolic Health in Obese Children With or Without Autism Spectrum Disorder: a Retrospective Cohort Study
Acronym: ROACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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