Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet

NCT ID: NCT06913985

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-20

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Cardiometabolic Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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).
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabet Borsheim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Research Institute

Locations

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Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Site Status

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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297969

Identifier Type: -

Identifier Source: org_study_id

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