Estudio de trayectoria: Predicción de la salud cardiometabólica en adolescentes y adultos jóvenes basado en la aptitud infantil, el sueño y la dieta (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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72202
- Arkansas Children's Hospital Research Institute
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Little Rock, Arkansas, Estados Unidos, 72202
- Arkansas Children's Nutrition Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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).
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite score of cardiometabolic health status.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elisabet Borsheim, Ph.D, Arkansas Children's Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 297969
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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