Studio della traiettoria: previsione della salute cardiometabolica negli adolescenti e nei giovani basati su fitness, sonno e dieta infantili (Trajectory)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72202
- Arkansas Children's Hospital Research Institute
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Little Rock, Arkansas, Stati Uniti, 72202
- Arkansas Children's Nutrition Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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).
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite score of cardiometabolic health status.
Lasso di tempo: Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)
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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)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Elisabet Borsheim, Ph.D, Arkansas Children's Research Institute
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 297969
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Informazioni su farmaci e dispositivi, documenti di studio
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