Autism Spectrum Disorder (ASD)ROACHNCT07804680
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
An observational study of Autism Spectrum Disorder (ASD) and Cardiometabolic Health Indicators, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Cardiometabolic Health Indicators, Cardiometabolic Risk Factors
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 31 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Obese Pediatrics with or without Autism Spectrum Disorder
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UVA Health
Charlottesville, Virginia, 22903
Aaron Meadows, MMed, 434-924-0395, fzj8tx@uvahealth.org
Aaron Meadows, MMed, 8592004427, erenmedos@gmail.com
About this study
Official title: Cardiorespiratory Fitness, Handgrip Strength, and Cardiometabolic Health in Obese Children With or Without Autism Spectrum Disorder: a Retrospective Cohort Study
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?
Read more
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
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder (ASD), Cardiometabolic Health Indicators, Cardiometabolic Risk Factors, Metabolic Syndrome, Prediabetes
- Keywords
- Cardiorespiratory Fitness, Metabolic Syndrome, Cardiometabolic Risk Factors, Prediabetes, Pediatrics, Austism Spectrum Disorder, Cardiometabolic Health Indicators, Fitness Testing, Handgrip Strength, Muscular Fitness
- Medical subject headings
- Autism Spectrum Disorder, Metabolic Syndrome, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatrics with Autism Spectrum Disorder | Obese and Prediabetic | |
| Pediatrics without Autism Spectrum Disorder | Obese and Pediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness
Cardiorespiratory Fitness as determined by 3-minute step test results, which includes post 1-minute heartrate per Kasch Pulse Recovery Test
Measured: January 1 - December 31 2026
Handgrip Strength
As defined by handgrip test using hand dynamometer in kilograms
Measured: January 1 - December 31 2026
Aerobic Capacity
Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test
Measured: January 1, 2026 to December 31, 2026
Secondary outcomes (8)
Prediabetes
As defined by HbA1c levels
Measured: January 1 - December 31 2026
Cardiometabolic Risk
As defined by blood pressure
Measured: January 1 - December 31 2026
Pediatric Obesity
As defined by BMI percentile > 95th percentile
Measured: January 1 - December 31 2026
LDL
As determined by level of low-density lipoprotein
Measured: January 1 - December 31 2026
HDL
As defined by high-density lipoprotein levels
Measured: January 1 - December 31 2026
Dyslipidemia
As defined by levels of Triglycerides
Measured: January 1 - December 31 2026
Cholesterolemia
As defined by level of total cholesterol
Measured: January 1 - December 31 2026
RHR
As defined by resting heart rate in beats per minute
Measured: January 1 - December 31 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start5 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron P. Meadows, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804680
- Sponsor's protocol ID
- 303916
- Acronym
- ROACH
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonney E, Ferguson G, Smits-Engelsman B. Relationship between Body Mass Index, Cardiorespiratory and Musculoskeletal Fitness among South African Adolescent Girls. Int J Environ Res Public Health. 2018 May 28;15(6):1087. doi: 10.3390/ijerph15061087.
PubMed 29843388Karagianni E, Antoniou V, Dimitriadis Z, Panagiotakos D, Cordovil R, Pepera G. Assessment of Overall Muscle Strength in Children and Adolescents Using Handheld Dynamometry: A Systematic Review of Reference Values and Quality of Data. J Clin Med. 2025 Nov 28;14(23):8454. doi: 10.3390/jcm14238454.
PubMed 41375762Zarate-Osuna F, Zapico AG, Gonzalez-Gross M. Handgrip Strength in Children and Adolescents Aged 3 to 16 Years and Residing in Spain: New Reference Values. Children (Basel). 2025 Apr 6;12(4):471. doi: 10.3390/children12040471.
PubMed 40310105Avitabile CM, Weber DR, Zemel BS. Paediatric dominant and non-dominant handgrip reference curves and the association with body composition. Ann Hum Biol. 2024 Feb;51(1):2298474. doi: 10.1080/03014460.2023.2298474. Epub 2024 Jan 22.
PubMed 38293777Kangalgil M, Meral B, Tiryaki BK, Bayram H. Paediatric handgrip reference curves and the relationship between lower handgrip strength and clinical outcomes of hospitalised children. J Paediatr Child Health. 2025 Feb;61(2):230-236. doi: 10.1111/jpc.16743. Epub 2024 Dec 12.
PubMed 39663848Richardson CG, Opotowsky AR, Chin C, Mays WA, Knecht SK, Powell AW. The Relationship of Handgrip Strength to Body Composition and Cardiopulmonary Fitness in Children and Young Adults. J Pediatr Clin Pract. 2025 Mar 20;16:200144. doi: 10.1016/j.jpedcp.2025.200144. eCollection 2025 Jun.
PubMed 40242788Jankowski M, Niedzielska A, Brzezinski M, Drabik J. Cardiorespiratory fitness in children: a simple screening test for population studies. Pediatr Cardiol. 2015 Jan;36(1):27-32. doi: 10.1007/s00246-014-0960-0. Epub 2014 Jul 29.
PubMed 25070386Gupta P, Kumar B, Banothu KK, Jain V. Assessment of Cardiorespiratory Fitness in 8-to-15-Year-Old Children with Overweight/Obesity by Three-Minute Step Test: Association with Degree of Obesity, Blood Pressure, and Insulin Resistance. Indian J Pediatr. 2023 Dec;90(12):1216-1222. doi: 10.1007/s12098-022-04311-z. Epub 2022 Sep 6.
PubMed 36066791Maggio ABR, Vuistiner P, Crettenand A, Tabin R, Martin XE, Beghetti M, Farpour-Lambert NJ, Deriaz O. Adapting the "Chester step test" to predict peak oxygen uptake in children. Swiss Med Wkly. 2017 May 10;147:w14435. doi: 10.4414/smw.2017.14435. eCollection 2017.
PubMed 28634968Weisstaub G, Gonzalez J, Orizola I, Borquez J, Monsalves-Alvarez M, Lera L, Troncoso R, Sepulveda C. Validity and reliability of the step test to estimate maximal oxygen consumption in pediatric population. Sci Rep. 2025 Jan 2;15(1):592. doi: 10.1038/s41598-024-84336-w.
PubMed 39747315Hayes RM, Maldonado D, Gossett T, Shepherd T, Mehta SP, Flesher SL. Developing and Validating a Step Test of Aerobic Fitness among Elementary School Children. Physiother Can. 2019 Spring;71(2):187-194. doi: 10.3138/ptc.2017-44.pp.
PubMed 31040514American College of Sports Medicine. ACSM's Guidelines for Exercise Testing and Prescription. 12th ed. Ozemek C, Bonikowske AR, Christle JW, Gallo PM, editors. Philadelphia, PA: Wolters Kluwer; 2025.
Rollo S, Fraser BJ, Seguin N, Sampson M, Lang JJ, Tomkinson GR, Tremblay MS. Health-Related Criterion-Referenced Cut-Points for Cardiorespiratory Fitness Among Youth: A Systematic Review. Sports Med. 2022 Jan;52(1):101-122. doi: 10.1007/s40279-021-01537-3. Epub 2021 Sep 1.
PubMed 34468952Griffith GJ, Wang AP, Liem RI, Carr MR, Corson T, Ward K. Reference Values for Cardiorespiratory Fitness in Patients Aged 6 to 18 Years. J Pediatr. 2024 Jan;264:113770. doi: 10.1016/j.jpeds.2023.113770. Epub 2023 Oct 5.
PubMed 37802386Ali OI, Sarsak HI, Tarshi MM, Marji M, Aljohani ST, Badawood MN, Bamusallam MM, Alharbi K, Ibrahim ZM, Sheeha BB, Amin WM. Assessment of Hand Grip and Pinch Strengths in Children with Autism Spectrum Disorders: A Cross-Sectional Study. Children (Basel). 2025 Mar 1;12(3):320. doi: 10.3390/children12030320.
PubMed 40150602