[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659211":3},{"organization":4,"outcomesModule":7,"designInfo":149,"detailedDescription":151,"studyPopulation":152,"armGroups":153,"interventions":148,"overallOfficials":157,"centralContacts":164,"locations":169,"responsibleParty":184,"collaborators":148,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":194,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":148,"studyType":201,"phases":148,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":218,"whyStopped":148,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":148},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,57,61,64,67,70,73,76,79,82,85,88,91,94,97,100,103,106,109,112,115,118,121,124,127,130,133,136,139,142,145],{"measure":15,"description":16,"timeFrame":12},"Body Weight","Body weight will be measured in kilograms using a calibrated scale.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"Calf Circumference","Calf circumference will be measured in centimeters at the maximum circumference of the dominant leg.",{"measure":24,"description":25,"timeFrame":12},"Systolic Blood Pressure","Systolic blood pressure will be measured in mmHg using a device validated for pediatric use and an appropriately sized cuff.",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":12},"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.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"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.",{"measure":39,"description":40,"timeFrame":12},"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.",{"measure":42,"description":43,"timeFrame":12},"Passive Tobacco Smoke Exposure Status","Passive tobacco smoke exposure will be assessed using protocol-defined structured questions administered to the parent\u002Flegal guardian and, when appropriate, to the participant. Exposure will be recorded as present or absent based on reported exposure at home, in vehicles, and\u002For other indoor environments.",{"measure":45,"description":46,"timeFrame":12},"Birth Weight","Birth weight will be recorded, when known, as reported by the parent or legal guardian.",{"measure":48,"description":49,"timeFrame":12},"Reported Chronic Health Conditions","Physician-diagnosed chronic conditions will be assessed by structured parent\u002Flegal guardian interview using protocol-defined categories. Diagnoses are reported by the parent\u002Flegal guardian and are not independently verified through clinical documentation.",{"measure":51,"description":52,"timeFrame":12},"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.",{"measure":54,"description":55,"timeFrame":56},"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.","Baseline and each optional reassessment through study completion, up to 10 years",{"measure":58,"description":59,"timeFrame":60},"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.","Each optional reassessment after baseline through study completion, up to 10 years",{"measure":62,"description":63,"timeFrame":12},"Height","Height will be measured in centimeters using a standard stadiometer.",{"measure":65,"description":66,"timeFrame":12},"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\u002Fm².",{"measure":68,"description":69,"timeFrame":12},"BMI-for-Age Z-Score","BMI-for-age z-score will be calculated using age- and sex-specific World Health Organization pediatric reference data.",{"measure":71,"description":72,"timeFrame":12},"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.",{"measure":74,"description":75,"timeFrame":12},"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.",{"measure":77,"description":78,"timeFrame":12},"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.",{"measure":80,"description":81,"timeFrame":12},"Triceps Skinfold Thickness","Triceps skinfold thickness will be measured in millimeters using a calibrated skinfold caliper on the non-dominant arm.",{"measure":83,"description":84,"timeFrame":12},"Diastolic Blood Pressure","Diastolic blood pressure will be measured in mmHg using a device validated for pediatric use and an appropriately sized cuff.",{"measure":86,"description":87,"timeFrame":12},"Pediatric Blood Pressure Category","Blood pressure will be classified according to pediatric reference criteria based on age, sex, and height.",{"measure":89,"description":90,"timeFrame":12},"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.",{"measure":92,"description":93,"timeFrame":12},"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.",{"measure":95,"description":96,"timeFrame":12},"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\u002Flegal guardian and\u002For the participant, as appropriate for age and maturity. Responses will be described according to the categories specified in the study data collection form.",{"measure":98,"description":99,"timeFrame":12},"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\u002Fweek), intermediate (5-6 days\u002Fweek), or unfavorable (0-4 days\u002Fweek).",{"measure":101,"description":102,"timeFrame":12},"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.",{"measure":104,"description":105,"timeFrame":12},"Weekly Average Recreational Screen Time","Weekly average recreational screen time will be calculated as \\[(school-day screen time × 5) + (weekend screen time × 2)\\] \u002F 7 and expressed in hours per day.",{"measure":107,"description":108,"timeFrame":12},"Recreational Screen Time Category","Participants will be classified according to weekly average recreational screen time as favorable (≤2 hours\u002Fday), intermediate (\\>2 to ≤4 hours\u002Fday), or unfavorable (\\>4 hours\u002Fday).",{"measure":110,"description":111,"timeFrame":12},"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.",{"measure":113,"description":114,"timeFrame":12},"Sleep Duration Category","Participants will be classified according to age-specific protocol-defined sleep duration categories as favorable, intermediate, or unfavorable.",{"measure":116,"description":117,"timeFrame":12},"Prematurity Status","Prematurity will be recorded as reported by the parent or legal guardian and classified as yes, no, or unknown.",{"measure":119,"description":120,"timeFrame":12},"Gestational Age at Birth","Gestational age at birth will be recorded in completed weeks, when known, as reported by the parent or legal guardian.",{"measure":122,"description":123,"timeFrame":12},"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.",{"measure":125,"description":126,"timeFrame":12},"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.",{"measure":128,"description":129,"timeFrame":12},"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.",{"measure":131,"description":132,"timeFrame":12},"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.",{"measure":134,"description":135,"timeFrame":12},"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.",{"measure":137,"description":138,"timeFrame":12},"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.",{"measure":140,"description":141,"timeFrame":12},"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.",{"measure":143,"description":144,"timeFrame":12},"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.",{"measure":146,"description":147,"timeFrame":12},"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.",null,{"allocation":148,"interventionModel":148,"interventionModelDescription":148,"primaryPurpose":148,"observationalModel":6,"timePerspective":150,"maskingInfo":148},"PROSPECTIVE","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.\n\nParticipants 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.\n\nThe 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.\n\nOptional 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).","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.",[154],{"label":155,"type":148,"description":156,"interventionNames":148},"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.",[158,161],{"name":159,"affiliation":5,"role":160},"Francesco Landi, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":162,"affiliation":5,"role":163},"Federica Mammarella, MD, PhD","STUDY_DIRECTOR",[165],{"name":159,"role":166,"phone":167,"phoneExt":148,"email":168},"CONTACT","+39 06 30154859","francesco.landi@policlinicogemelli.it",[170],{"facility":5,"status":148,"city":171,"state":172,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":181,"contacts":182},"Rome","Lazio","00168","Italy","IT",{"type":177,"coordinates":178},"Point",[179,180],12.51133,41.89193,{"lat":180,"lon":179},[183],{"name":159,"role":166,"phone":167,"phoneExt":148,"email":168},{"type":185,"investigatorFullName":148,"investigatorTitle":148,"investigatorAffiliation":148,"oldNameTitle":148,"oldOrganization":148},"SPONSOR","100659211","non-invasive-assessment-of-early-health-determinants-in-children-and-adolescents-100659211",false,"NCT07861516","Non-Invasive Assessment of Early Health Determinants in Children and Adolescents","LONGEVITY-NEXT: Valutazione Non Invasiva Dei Determinanti Precoci Della Salute Cardiometabolica, Funzionale e Comportamentale in Bambini e Adolescenti","LONGEVITY-NEXT","Inclusion Criteria:\n\n* Age 6 to 17 years at the time of assessment.\n* 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.\n* Assent of the minor obtained using age- and maturity-appropriate procedures and documentation.\n* Willingness of the child\u002Fadolescent and family to participate in the non-invasive assessment, even if individual measurements, tests, or information cannot be obtained.\n\nExclusion Criteria:\n\n* Age younger than 6 years or older than 17 years at the time of assessment.\n* 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.\n* Failure to obtain the minor's assent using age- and maturity-appropriate procedures.\n* Explicit objection by the minor to study participation or continuation of the assessment.\n* Acute clinical conditions, illness, significant discomfort, or other circumstances that, in the investigator's judgment, make participation temporarily inappropriate.\n* Refusal of the personal data processing required for study participation.",true,"ALL","6 Years","17 Years",{"count":199,"type":200},2000,"ESTIMATED","OBSERVATIONAL","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.",[204,205],"Cardiometabolic Health Indicators","Child Health",[207,208,209,210,211,212,213,214,215,216,217],"Pediatric Health","Cardiometabolic Health","Life-Course Health","Mediterranean Diet","Physical Activity","Sedentary Behavior","Screen Time","Sleep Duration","Tobacco Smoke Exposure","Handgrip Strength","Health Promotion","NOT_YET_RECRUITING","2026-10-01",{"date":221,"type":222},"2026-10-06","ACTUAL",{"date":219,"type":200},{"date":225,"type":200},"2036-10-01",{"name":5,"class":6},1]