[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639143":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":96,"collaborators":98,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":24,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Istituto per la Ricerca e l'Innovazione Biomedica","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Participants will use the full version of the DELPHI platform, including wearable sensors, mobile app-based data collection, personalized recommendations generated through artificial intelligence algorithms, multimedia content (physical exercises, mindfulness activities, and educational videos), as well as interactive notifications and feedback.",[13],"Other: DELPHI Personalized Digital Prevention Platform",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Participants will access a limited version of the application restricted to passive monitoring functions only, without personalized recommendations, adaptive content, or interactive notifications.",[18],"Other: Passive Digital Monitoring Control",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DELPHI Personalized Digital Prevention Platform","the full version of the DELPHI digital platform, designed to support personalized primary prevention and health promotion. The intervention includes continuous monitoring through wearable sensors (Fitbit Inspire 3), mobile app-based data collection, and adaptive lifestyle recommendations generated by artificial intelligence algorithms within a Human Digital Twin framework.\n\nParticipants will receive personalized feedback and notifications related to physical activity, sleep, nutrition, hydration, stress management, and psychological well-being. The platform also delivers multimedia educational content, including guided exercises, mindfulness and breathing practices, wellness educational videos, and behavioral micro-actions. Data collected through wearable devices, digital questionnaires, and behavioral monitoring are used to dynamically tailor recommendations and preventive strategies throughout the study period.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Passive Digital Monitoring Control","Participants assigned to the control group will use a limited version of the DELPHI application restricted to passive monitoring functions. The application will collect data from wearable devices and questionnaires related to physical activity, sleep, nutrition, and well-being, but participants will not receive personalized recommendations, adaptive educational content, interactive feedback, or behavioral notifications.\n\nThe control condition is intended to provide observational digital monitoring only, without active preventive intervention or AI-based personalization.",[15],[30],{"name":31,"affiliation":32,"role":33},"Gennaro Tartarisco","Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR)","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","+393283377046","gennaro.tartarisco@irib.cnr.it",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Maria Valeria Maiorana","mariavaleria.maiorana@irib.cnr.it",[43],{"facility":32,"status":44,"city":45,"state":24,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Messina","98164","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],15.55256,38.19394,{"lat":53,"lon":52},[56,60,61,63,65,67,69,71,73,75,77,79,80,82,84,86,88,90,92,94],{"name":57,"role":36,"phone":58,"phoneExt":24,"email":59},"Serena Iacono Isidoro","+393281655820","serena.iaconoisidoro@irib.cnr.it",{"name":31,"role":33,"phone":24,"phoneExt":24,"email":24},{"name":57,"role":62,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":64,"role":62,"phone":24,"phoneExt":24,"email":24},"Irene Aprile",{"name":66,"role":62,"phone":24,"phoneExt":24,"email":24},"Renato Tino",{"name":68,"role":62,"phone":24,"phoneExt":24,"email":24},"Mariacristina Siotto",{"name":70,"role":62,"phone":24,"phoneExt":24,"email":24},"Marco Germanotta",{"name":72,"role":62,"phone":24,"phoneExt":24,"email":24},"Alessandro Guerrini",{"name":74,"role":62,"phone":24,"phoneExt":24,"email":24},"Monia Andrea Papa",{"name":76,"role":62,"phone":24,"phoneExt":24,"email":24},"Roberta Bruschetta",{"name":78,"role":62,"phone":24,"phoneExt":24,"email":24},"Simona Campisi",{"name":40,"role":62,"phone":24,"phoneExt":24,"email":24},{"name":81,"role":62,"phone":24,"phoneExt":24,"email":24},"Giorgia Bruschetta",{"name":83,"role":62,"phone":24,"phoneExt":24,"email":24},"Concetta Polizzi",{"name":85,"role":62,"phone":24,"phoneExt":24,"email":24},"Barbara Caci",{"name":87,"role":62,"phone":24,"phoneExt":24,"email":24},"Maria Cocchiara",{"name":89,"role":62,"phone":24,"phoneExt":24,"email":24},"Flavia Altavilla",{"name":91,"role":62,"phone":24,"phoneExt":24,"email":24},"Alessia Valdesi",{"name":93,"role":62,"phone":24,"phoneExt":24,"email":24},"Chiara Urone",{"name":95,"role":62,"phone":24,"phoneExt":24,"email":24},"Giulia Giordano",{"type":33,"investigatorFullName":31,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Head of Unit",[99,101,103],{"name":100,"class":6},"Fondazione Don Carlo Gnocchi Onlus",{"name":102,"class":6},"Universita degli Studi di Palermo",{"name":104,"class":105},"Medilink s.r.l.","UNKNOWN","100639143","digital-engagement-for-lifelong-health-100639143",false,"NCT07612852","Digital Engagement for Lifelong Health","Digital Engagement for Lifelong Prevention and Health Improvement","DELPHI","Inclusion Criteria:\n\n* Apparent good general health status, confirmed by medical history and initial self-assessment.\n* Ability to understand the study information and provide informed consent.\n* Availability and motivation to participate for the entire duration of the study (12 months).\n* Access to a smartphone compatible with the DELPHI application.\n* Willingness to wear the wearable devices for continuous monitoring of physiological parameters.\n* Basic familiarity with mobile applications or willingness to receive training on their use.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of severe chronic diseases in active phase (e.g., oncological, cardiovascular, or neurological diseases).\n* Acute or unstable conditions that could compromise participation in the protocol.\n* Current pregnancy.\n* Diagnosed major cognitive or psychiatric disorders that hinder understanding of or adherence to the protocol.\n* Current use of medications that significantly affect the parameters being monitored (e.g., psychotropic drugs, beta-blockers).\n* Simultaneous participation in other clinical studies.\n* Logistical difficulties that prevent frequent interaction with the platform (e.g., lack of connection, unwillingness to attend periodic follow-ups).",true,"ALL","18 Years","65 Years",{"count":119,"type":120},200,"ESTIMATED","INTERVENTIONAL",[123],"NA","The DELPHI project (Digital Engagement for Lifelong Prevention and Health Improvement) aims to develop, implement, and validate an advanced digital platform for promoting well-being and personalized prevention of chronic non-communicable diseases in healthy adults. By integrating wearable sensors, artificial intelligence, federated learning, and the Human Digital Twin (HDT) paradigm, the DELPHI platform is designed to collect, analyze, and interpret multidimensional data in order to deliver dynamic and personalized recommendations for healthy lifestyles.\n\nThe study adopts a multicenter, randomized controlled pilot design, with a maximum duration of 12 months per participant. A total of 200 healthy adults aged 18-65 will be recruited in Southern Italy (Sicily, Campania, and Basilicata) and randomly assigned to either: (1) an experimental group using the full DELPHI platform, including personalized recommendations, adaptive content, and continuous feedback; or (2) a control group using a basic version limited to passive monitoring.\n\nAs a non-clinical primary prevention pilot study, DELPHI aims to assess the operational feasibility, usability, and acceptability of the platform in real-world settings, while also exploring preliminary signals of impact on health and lifestyle domains without confirmatory purposes. Secondary objectives include monitoring physiological indicators, adherence to the app and wearable devices, and evaluating the feasibility of implementing the platform in workplace environments.\n\nData collection will rely on wearable devices, digital questionnaires, and behavioral analysis, with strong safeguards for personal data protection in compliance with GDPR and advanced security approaches such as federated learning and encryption.\n\nSpecific subgroups, including workers from the Fondazione Don Carlo Gnocchi (FDG) as well as university staff and students, will be involved in targeted assessments related to mental well-being and distress. In addition, workers from the FDG will test a virtual reality module designed to evaluate biomechanical overload risks during manual handling activities in simulated environments. These additional physiological and virtual reality components are exploratory and non-diagnostic.\n\nOverall, DELPHI seeks to provide a solid foundation for the adoption of predictive and personalized models in digital health, contributing to the development of a sustainable and accessible prevention ecosystem, particularly in Southern Italy.",[126,127,128],"Life Style, Healthy","Risk Reduction","Health Promotion",[130,131,132],"health","digitalization","prevention","2026-05-25",{"date":135,"type":136},"2026-05-29","ACTUAL",{"date":138,"type":136},"2026-05-04",{"date":140,"type":120},"2027-03-30",{"name":5,"class":6},1]