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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorUniversity of Virginia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Obese Pediatrics with or without Autism Spectrum Disorder

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Pediatrics with Autism Spectrum Disorder
Group B: Pediatrics without Autism Spectrum Disorder

Trial outcomes

Primary outcomes

1

Cardiorespiratory Fitness

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
2

Handgrip Strength

As defined by handgrip test using hand dynamometer in kilograms

Time frame
January 1 - December 31 2026
3

Aerobic Capacity

Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test

Time frame
January 1, 2026 to December 31, 2026

Secondary outcomes

1

Prediabetes

As defined by HbA1c levels

Time frame
January 1 - December 31 2026
2

Cardiometabolic Risk

As defined by blood pressure

Time frame
January 1 - December 31 2026
3

Pediatric Obesity

As defined by BMI percentile \> 95th percentile

Time frame
January 1 - December 31 2026
4

LDL

As determined by level of low-density lipoprotein

Time frame
January 1 - December 31 2026

Other outcomes

Sponsors and contacts

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