Cardiometabolic Health IndicatorsLONGEVITY-NEXTNCT07861516
Non-Invasive Assessment of Early Health Determinants in Children and Adolescents
An observational study of Cardiometabolic Health Indicators and Child Health, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health Indicators, Child Health
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 1 Oct 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Francesco Landi, MD, PhD, +39 06 30154859, francesco.landi@policlinicogemelli.it
About this study
Official title: LONGEVITY-NEXT: Valutazione Non Invasiva Dei Determinanti Precoci Della Salute Cardiometabolica, Funzionale e Comportamentale in Bambini e Adolescenti
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.
Read the detailed description
LONGEVITY-NEXT is a single-center, non-profit, non-interventional, minimal-risk pediatric observational study developed in scientific and methodological continuity with the adult Longevity Check-up program, while constituting an independent study specifically adapted to children and adolescents. The study is based primarily on a cross-sectional baseline assessment using exclusively non-invasive procedures.
Participants may be enrolled at Fondazione Policlinico Universitario Agostino Gemelli IRCCS or during health-promotion, community, school, or Longevity-related initiatives organized, authorized, or coordinated by the Sponsor. These territorial activities are operational settings of the same single-center study and do not constitute independent study sites.
The assessment includes anthropometric measurements, blood pressure and heart rate, handgrip strength, adherence to the Mediterranean diet using the KIDMED questionnaire, reported frequency of processed or ultra-processed food intake, physical activity, recreational screen time, habitual sleep duration, tobacco smoke exposure, early-life factors, chronic health conditions, and family cardiometabolic history.
Optional observational reassessments may occur during subsequent LONGEVITY-NEXT initiatives. These reassessments are voluntary, opportunistic, and are not scheduled at predefined intervals. No reassessment will be performed after the participant reaches 18 years of age. No experimental treatment, investigational medical device, invasive procedure, or modification of usual clinical care is involved. Exploratory analyses will assess associations among the individually registered cardiometabolic, functional, behavioral, environmental, early-life, and family measures using statistical methods appropriate to the nature of the variables. Where specifically authorized pseudonymized parent-child linkage is available, exploratory analyses will also assess relationships between the child's profile and corresponding or complementary measures available for participating parent(s).
- Conditions
- Cardiometabolic Health Indicators, Child Health
- Keywords
- Pediatric Health, Cardiometabolic Health, Life-Course Health, Mediterranean Diet, Physical Activity, Sedentary Behavior, Screen Time, Sleep Duration, Tobacco Smoke Exposure, Handgrip Strength, Health Promotion
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and Adolescents Aged 6-17 Years | Children and adolescents aged 6 to 17 years from the general population who voluntarily participate in LONGEVITY-NEXT and undergo the non-invasive multidimensional assessment specified in the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (44)
Body Weight
Body weight will be measured in kilograms using a calibrated scale.
Measured: Baseline
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.
Measured: Baseline
Calf Circumference
Calf circumference will be measured in centimeters at the maximum circumference of the dominant leg.
Measured: Baseline
Systolic Blood Pressure
Systolic blood pressure will be measured in mmHg using a device validated for pediatric use and an appropriately sized cuff.
Measured: Baseline
Right-Hand Handgrip Strength
Right-hand handgrip strength will be measured in kilograms using an adjustable dynamometer suitable for pediatric use. The best value obtained from two trials will be recorded.
Measured: Baseline
KIDMED Score
Adherence to the Mediterranean diet will be assessed using the KIDMED questionnaire. The total KIDMED score will be calculated according to the original scoring system, with higher scores indicating greater adherence to the Mediterranean diet.
Measured: Baseline
Days With at Least 60 Minutes of Moderate-to-Vigorous Physical Activity
Physical activity will be assessed as the number of days during the previous 7 days in which the participant accumulated at least 60 minutes of moderate-to-vigorous physical activity.
Measured: Baseline
Recreational Screen Time on School Days
Recreational screen time on school days will be assessed in hours per day, including television, video or streaming, videogames, smartphones, tablets, and computers used for non-school purposes.
Measured: Baseline
Habitual Sleep Duration on School Days
Habitual nocturnal sleep duration on school days will be estimated from reported sleep onset and wake times and expressed in hours per night.
Measured: Baseline
Passive Tobacco Smoke Exposure Status
Passive tobacco smoke exposure will be assessed using protocol-defined structured questions administered to the parent/legal guardian and, when appropriate, to the participant. Exposure will be recorded as present or absent based on reported exposure at home, in vehicles, and/or other indoor environments.
Measured: Baseline
Birth Weight
Birth weight will be recorded, when known, as reported by the parent or legal guardian.
Measured: Baseline
Reported Chronic Health Conditions
Physician-diagnosed chronic conditions will be assessed by structured parent/legal guardian interview using protocol-defined categories. Diagnoses are reported by the parent/legal guardian and are not independently verified through clinical documentation.
Measured: Baseline
Proportion of Participants With Waist-to-Height Ratio ≥0.50
The proportion of participants with a waist-to-height ratio ≥0.50 will be calculated.
Measured: Baseline
Change From Baseline in the Number of Unfavorable Health Domains
Among participants with at least one optional reassessment, the change from baseline in the total number of unfavorable protocol-defined health domains will be calculated. The total count is based on seven domains: weight status, blood pressure, adherence to the Mediterranean diet, physical activity, recreational screen time, sleep duration, and tobacco smoke exposure. Negative values indicate fewer unfavorable domains and positive values indicate more unfavorable domains compared with baseline.
Measured: Baseline and each optional reassessment through study completion, up to 10 years
Number of Unfavorable Health Domains at Optional Reassessment
Among participants undergoing an optional reassessment, the total number of unfavorable protocol-defined health domains will be calculated using the same seven domains assessed at baseline: weight status, blood pressure, adherence to the Mediterranean diet, physical activity, recreational screen time, sleep duration, and tobacco smoke exposure. The total score ranges from 0 to 7, with higher values indicating a greater number of unfavorable health domains.
Measured: Each optional reassessment after baseline through study completion, up to 10 years
Height
Height will be measured in centimeters using a standard stadiometer.
Measured: Baseline
Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and expressed as kg/m².
Measured: Baseline
BMI-for-Age Z-Score
BMI-for-age z-score will be calculated using age- and sex-specific World Health Organization pediatric reference data.
Measured: Baseline
Pediatric Weight Status Category
Weight status will be classified according to World Health Organization BMI-for-age criteria as severe thinness, thinness, normal weight, overweight, or obesity.
Measured: Baseline
Waist-to-Height Ratio
Waist-to-height ratio will be calculated as waist circumference in centimeters divided by height in centimeters and expressed as a dimensionless ratio.
Measured: Baseline
Mid-Upper Arm Circumference
Mid-upper arm circumference will be measured in centimeters at the midpoint between the acromion and olecranon of the non-dominant arm.
Measured: Baseline
Triceps Skinfold Thickness
Triceps skinfold thickness will be measured in millimeters using a calibrated skinfold caliper on the non-dominant arm.
Measured: Baseline
Diastolic Blood Pressure
Diastolic blood pressure will be measured in mmHg using a device validated for pediatric use and an appropriately sized cuff.
Measured: Baseline
Pediatric Blood Pressure Category
Blood pressure will be classified according to pediatric reference criteria based on age, sex, and height.
Measured: Baseline
Left-Hand Handgrip Strength
Left-hand handgrip strength will be measured in kilograms using an adjustable dynamometer suitable for pediatric use. The best value obtained from two trials will be recorded.
Measured: Baseline
KIDMED Adherence Category
Participants will be classified according to the KIDMED score as having low adherence (score ≤3), intermediate adherence (score 4-7), or high adherence (score ≥8) to the Mediterranean diet.
Measured: Baseline
Reported Frequency of Processed or Ultra-Processed Food Intake
Reported frequency of processed or ultra-processed food intake will be assessed using protocol-defined structured frequency questions administered to the parent/legal guardian and/or the participant, as appropriate for age and maturity. Responses will be described according to the categories specified in the study data collection form.
Measured: Baseline
Physical Activity Category
Participants will be classified according to the number of days during the previous 7 days with at least 60 minutes of moderate-to-vigorous physical activity as favorable (7 days/week), intermediate (5-6 days/week), or unfavorable (0-4 days/week).
Measured: Baseline
Recreational Screen Time on Weekends
Recreational screen time on weekends will be assessed in hours per day, including television, video or streaming, videogames, smartphones, tablets, and computers used for non-school purposes.
Measured: Baseline
Weekly Average Recreational Screen Time
Weekly average recreational screen time will be calculated as [(school-day screen time × 5) + (weekend screen time × 2)] / 7 and expressed in hours per day.
Measured: Baseline
Recreational Screen Time Category
Participants will be classified according to weekly average recreational screen time as favorable (≤2 hours/day), intermediate (>2 to ≤4 hours/day), or unfavorable (>4 hours/day).
Measured: Baseline
Habitual Sleep Duration on Weekends
Habitual nocturnal sleep duration on weekends will be estimated from reported sleep onset and wake times and expressed in hours per night.
Measured: Baseline
Sleep Duration Category
Participants will be classified according to age-specific protocol-defined sleep duration categories as favorable, intermediate, or unfavorable.
Measured: Baseline
Prematurity Status
Prematurity will be recorded as reported by the parent or legal guardian and classified as yes, no, or unknown.
Measured: Baseline
Gestational Age at Birth
Gestational age at birth will be recorded in completed weeks, when known, as reported by the parent or legal guardian.
Measured: Baseline
Family History of Diabetes Mellitus
Reported family history of diabetes mellitus will be assessed by structured parent or legal guardian interview and recorded as present or absent.
Measured: Baseline
Family History of Obesity
Reported family history of obesity will be assessed by structured parent or legal guardian interview and recorded as present or absent.
Measured: Baseline
Family History of Hypercholesterolemia
Reported family history of hypercholesterolemia will be assessed by structured parent or legal guardian interview and recorded as present or absent.
Measured: Baseline
Family History of Premature Myocardial Infarction
Reported family history of premature myocardial infarction will be assessed by structured parent or legal guardian interview and recorded as present or absent. Premature myocardial infarction is defined as an event occurring before age 55 years in male relatives or before age 65 years in female relatives.
Measured: Baseline
Family History of Stroke
Reported family history of stroke will be assessed by structured parent or legal guardian interview and recorded as present or absent.
Measured: Baseline
Family History of Other Cardiovascular Disease
Reported family history of other cardiovascular disease will be assessed by structured parent or legal guardian interview and recorded as present or absent.
Measured: Baseline
Frequency of Passive Tobacco Smoke Exposure
Among participants with reported passive tobacco smoke exposure, the frequency of exposure will be assessed using protocol-defined structured questions and described according to the categories recorded in the study data collection form.
Measured: Baseline
Active Smoking Status
When appropriate according to the participant's age and maturity, current active smoking status will be assessed using protocol-defined structured questions and recorded as reported active smoking present or absent.
Measured: Baseline
Frequency of Active Smoking
Among participants reporting active smoking, and when appropriate according to age and maturity, the reported frequency of active smoking will be recorded using protocol-defined structured questions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2036 (estimated)
- Study completion1 Oct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Health IndicatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Landi, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSFederica Mammarella, MD, PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861516
- Sponsor's protocol ID
- 27848
- Acronym
- LONGEVITY-NEXT
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No