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Enrolling by invitation NCT06913985

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

— Observational Cardiometabolic Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiometabolic Health. Basic parameters: 13 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • 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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Arkansas Children's Hospital Research Institute — Little Rock
  • Arkansas Children's Nutrition Center — Little Rock

Identifiers

NCT: NCT06913985 · 297969

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗