Clinical trial NCT06913985: Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Official title: Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiometabolic Health
Keywords: diet
physical fitness
adolescents
children
longitudinal study
diet quality
sleep quality
cardiovascular risk prediction
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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
* 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

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).

Primary outcomes:
measure: Composite score of cardiometabolic health status.
timeFrame: Baseline assessment in childhood (ages 7-10) and follow-up assessment during adolescence or early adulthood (ages 13-21)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Elisabet Borsheim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: