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Clinical Trials in Italy / NCT07861516
Starting soon Observational

Non-Invasive Assessment of Early Health Determinants in Children and Adolescents

NCT07861516 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2026-10-01
Last updated
2026-10-06

Condition(s) studied

Cardiometabolic Health IndicatorsChild Health

Study summary

LONGEVITY-NEXT is a single-center, non-profit observational study designed to assess early non-invasive determinants of cardiometabolic, functional, behavioral, and environmental health in children and adolescents aged 6 to 17 years from the general population. Participants will undergo a standardized 15-20-minute non-invasive assessment including anthropometric measurements, blood pressure and heart rate, handgrip strength, dietary habits and adherence to the Mediterranean diet, physical activity, recreational screen time, sleep duration, tobacco smoke exposure, early-life factors, chronic health conditions, and family cardiometabolic history. The primary outcome is the distribution of the number of unfavorable cardiometabolic, behavioral, and environmental health domains per participant. The study involves no experimental treatment, drug, investigational medical device, invasive procedure, or modification of usual care. Optional repeated assessments may occur opportunistically during the study while participants remain between 6 and 17 years of age.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age 6 to 17 years at the time of assessment. * Written informed consent for study participation and personal data processing provided by both parents exercising parental responsibility or, when applicable, by the legally appointed guardian, according to applicable regulations and Ethics Committee-approved procedures. * Assent of the minor obtained using age- and maturity-appropriate procedures and documentation. * Willingness of the child/adolescent and family to participate in the non-invasive assessment, even if individual measurements, tests, or information cannot be obtained. Exclusion Criteria: * Age younger than 6 years or older than 17 years at the time of assessment. * Failure to obtain the required written informed consent for study participation and personal data processing from both parents exercising parental responsibility, where applicable, or from the legally appointed guardian. * Failure to obtain the minor's assent using age- and maturity-appropriate procedures. * Explicit objection by the minor to study participation or continuation of the assessment. * Acute clinical conditions, illness, significant discomfort, or other circumstances that, in the investigator's judgment, make participation temporarily inappropriate. * Refusal of the personal data processing required for study participation.

Primary outcome measure(s)

  • Number of Unfavorable Cardiometabolic, Behavioral, and Environmental Health Domains per Participant — Baseline
    For each participant, a count will be calculated across seven protocol-defined domains: weight status, blood pressure, adherence to the Mediterranean diet, physical activity, recreational screen time, sleep duration, and tobacco smoke exposure. Each domain classified as unfavorable contributes one point. The total count ranges from 0 to 7, with higher values indicating a greater number of unfavorable domains.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861516 on ClinicalTrials.gov ↗ ← All trials in Italy