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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Children and adolescents aged 6 to 17 years from the general population who voluntarily participate in LONGEVITY-NEXT and meet the protocol-defined eligibility criteria. Participants may be enrolled at Fondazione Policlinico Universitario Agostino Gemelli IRCCS or during health-promotion, community, school, or other territorial initiatives organized, authorized, or coordinated by the Sponsor. The presence of chronic conditions or functional limitations does not in itself preclude participation, provided that study participation is considered appropriate.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Children and Adolescents Aged 6-17 Years

Trial outcomes

Primary outcomes

1

Number of Unfavorable Cardiometabolic, Behavioral, and Environmental Health Domains per Participant

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.

Time frame
Baseline

Secondary outcomes

1

Body Weight

Body weight will be measured in kilograms using a calibrated scale.

Time frame
Baseline
2

Waist Circumference

Waist circumference will be measured in centimeters using a flexible non-stretchable tape at the midpoint between the lower margin of the last palpable rib and the iliac crest.

Time frame
Baseline
3

Calf Circumference

Calf circumference will be measured in centimeters at the maximum circumference of the dominant leg.

Time frame
Baseline
4

Systolic Blood Pressure

Systolic blood pressure will be measured in mmHg using a device validated for pediatric use and an appropriately sized cuff.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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