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

NCT06913985 | Enrolling By Invitation

• 1 other identifier: 297969
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiometabolic Health

Keywords

diet; physical fitness; adolescents; children; longitudinal study; diet quality; sleep quality; cardiovascular risk prediction

Outcome Measures

Primary Outcomes (1)

• 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 \[DXA-derived fat mass index (kg/m²)\].

  Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (2)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Elisabet Borsheim, Ph.D

  Arkansas Children's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 2, 2025

Record last verified: 2025-05

Locations

US (2)