Cardiometabolic HealthTrajectoryNCT06913985
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
An observational study of Cardiometabolic Health, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
Trial summary
The Trajectory study aims to determine whether childhood aerobic fitness, sleep quality, and diet quality predict cardiometabolic health during puberty and early adulthood, independently of adiposity. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Cardiometabolic Health
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents (13 to 17 years) and young adults (18 to 21 years) who previously participated in the Arkansas Active Kids study (clinicaltrials.gov #NCT03221673; IRB #206217) and the MI Energy study (clinicaltrials.gov #NCT04427462; IRB #260376).
Who may be able to join
- Ages 13 to 21 years.
- Boys or girls.
- All ethnicities.
- All BMIs.
- Previous participation in the Arkansas Active Kids study and the MI Energy study.
- Participants who previously agreed to be contacted for future research at ACNC.
- Participants who agree to the use of their previously collected information and samples from the AAK or MI Energy studies for the follow-up study.
Who cannot join
- Asthma that requires daily use of inhalers to keep symptoms under control.
- Asthma that requires use of rescue inhalers (e.g., albuterol) >2 days per week.
- Exercise-induced asthma.
- Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
- Neurological disorders (e.g. epilepsy or seizures).
- Cancer.
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- Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).
- Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis).
- Bleeding disorders (e.g., hemophilia).
- Chronic infections (e.g., HIV, hepatitis B, hepatitis C).
- Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
- Pregnancy (verbal assessment).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
The Trajectory study aims to determine whether childhood aerobic fitness, sleep quality, and diet quality predict cardiometabolic health during puberty and early adulthood, independently of adiposity.
Read the detailed description
The Trajectory study is a longitudinal observational study. Participants will be recalled from two existing pediatric cohorts: the Arkansas Active Kids study (ClinicalTrials.gov ID: NCT03221673; IRB #206217) and the MI Energy study (ClinicalTrials.gov ID: NCT04427462; IRB #260376). Both were cross-sectional studies with comparable designs, recruiting children between ages 7 and 10 years, regardless of sex, BMI, or ethnicity. The Trajectory study serves as the follow-up component during adolescence or early adulthood (ages 13-21). It is anticipated that approximately 250 participants will complete the follow-up visit.
During the follow-up visit at the Arkansas Children's Nutrition Center (ACNC), the following key measurements will be conducted:
- Body Composition: Dual-Energy X-ray Absorptiometry (DXA)
- Metabolic Profile: Fasting blood markers, including glucose, lipid profile, and insulin resistance
- Continuous Glucose Monitoring: Interstitial sensor-based glucose
- Vascular Function: Ultrasound (brachial artery flow-mediated dilation)
- Liver Examination: Ultrasound (liver steatosis and stiffness)
- Resting Metabolic Rate: Indirect calorimetry
- Aerobic Capacity: Cardiopulmonary exercise test (spirometry)
- Muscle Strength: Dynamometry
- Physical Activity \& Sleep: Accelerometry
- Dietary Intake: Food frequency questionary
- Conditions
- Cardiometabolic Health
- Keywords
- diet, physical fitness, adolescents, children, longitudinal study, diet quality, sleep quality, cardiovascular risk prediction
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of cardiometabolic health status.
This composite outcome evaluates cardiometabolic health across two time points (pre-/early-adolescence and adolescence/early adulthood). It is calculated as the mean of z-scores for: fasting triglycerides and total cholesterol/HDL ratio (from fasting blood samples), HOMA2-IR (from fasting glucose and insulin), systolic blood pressure (automated sphygmomanometer), fat mass index [DXA-derived fat mass (kg)/height²], and inverse peak oxygen uptake (measured via graded exercise test with indirect calorimetry). The composite provides an overall measure of cardiometabolic health status. The goal is to assess whether childhood aerobic fitness, sleep quality, and diet quality independently predict this score, controlling for adiposity [DXA-derived fat mass index (kg/m²)].
Measured: Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic HealthStudies 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, Ph.D, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913985
- Sponsor's protocol ID
- 297969
- Acronym
- Trajectory
- Status last verified
- Nov 2026
- First submitted
- 31 Mar 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
- ClinicalTrials.gov ID
- NCT06913985
- Acronym / sponsor ID
- Trajectory / 297969
- Conditions
- Cardiometabolic Health
- Keywords
- diet, physical fitness, adolescents, children, longitudinal study, diet quality, sleep quality, cardiovascular risk prediction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Trajectory study aims to determine whether childhood aerobic fitness, sleep quality, and diet quality predict cardiometabolic health during puberty and early adulthood, independently of adiposity.
Detailed description
The Trajectory study is a longitudinal observational study. Participants will be recalled from two existing pediatric cohorts: the Arkansas Active Kids study (ClinicalTrials.gov ID: NCT03221673; IRB #206217) and the MI Energy study (ClinicalTrials.gov ID: NCT04427462; IRB #260376). Both were cross-sectional studies with comparable designs, recruiting children between ages 7 and 10 years, regardless of sex, BMI, or ethnicity. The Trajectory study serves as the follow-up component during adolescence or early adulthood (ages 13-21). It is anticipated that approximately 250 participants will complete the follow-up visit.
During the follow-up visit at the Arkansas Children's Nutrition Center (ACNC), the following key measurements will be conducted:
- Body Composition: Dual-Energy X-ray Absorptiometry (DXA)
- Metabolic Profile: Fasting blood markers, including glucose, lipid profile, and insulin resistance
- Continuous Glucose Monitoring: Interstitial sensor-based glucose
- Vascular Function: Ultrasound (brachial artery flow-mediated dilation)
- Liver Examination: Ultrasound (liver steatosis and stiffness)
- Resting Metabolic Rate: Indirect calorimetry
- Aerobic Capacity: Cardiopulmonary exercise test (spirometry)
- Muscle Strength: Dynamometry
- Physical Activity \& Sleep: Accelerometry
- Dietary Intake: Food frequency questionary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents (13 to 17 years) and young adults (18 to 21 years) who previously participated in the Arkansas Active Kids study (clinicaltrials.gov #NCT03221673; IRB #206217) and the MI Energy study (clinicaltrials.gov #NCT04427462; IRB #260376).
Key inclusion criteria (7 listed)
- Ages 13 to 21 years.
- Boys or girls.
- All ethnicities.
- All BMIs.
- Previous participation in the Arkansas Active Kids study and the MI Energy study.
Key exclusion criteria (12 listed)
- Asthma that requires daily use of inhalers to keep symptoms under control.
- Asthma that requires use of rescue inhalers (e.g., albuterol) >2 days per week.
- Exercise-induced asthma.
- Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
- Neurological disorders (e.g. epilepsy or seizures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite score of cardiometabolic health status.
Time frame: Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)
This composite outcome evaluates cardiometabolic health across two time points (pre-/early-adolescence and adolescence/early adulthood). It is calculated as the mean of z-scores for: fasting triglycerides and total cholesterol/HDL ratio (from fasting blood samples), HOMA2-IR (from fasting glucose and insulin), systolic blood pressure (automated sphygmomanometer), fat mass index [DXA-derived fat mass (kg)/height²], and inverse peak oxygen uptake (measured via graded exercise test with indirect calorimetry). The composite provides an overall measure of cardiometabolic health status. The goal is to assess whether childhood aerobic fitness, sleep quality, and diet quality independently predict this score, controlling for adiposity [DXA-derived fat mass index (kg/m²)].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabet Borsheim, Ph.D principal investigator
Arkansas Children's Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Health, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score of cardiometabolic health status. (time frame: Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.