[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611242":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":37,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DDM General Population Cohort",null,"This cohort includes adults residing in the Netherlands who voluntarily participate in the Data Donation Model (DDM) through the TRAIN Health Awareness Platform. Participants provide electronic informed consent, connect wearable devices or health apps, and share lifestyle and wellbeing data for up to five years. An optional 12-week TRAIN Heart Journey module offers guided feedback on activity, sleep, and stress, but participation in this module is not required for data donation.\n\nParticipants can modify or withdraw consent at any time. No randomisation, assignment, or blinding is used.",[13],"Other: Digital Lifestyle Feedback Module (optional)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Digital Lifestyle Feedback Module (optional)","An optional 12-week digital feedback module offered within the TRAIN platform to participants who choose to engage with guided lifestyle support. This is not an assigned intervention but part of the broader participatory data-donation framework.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Nimrat Grewal, MD, PhD","CONTACT","+31 20 566 9111","n.grewal@amsterdamumc.nl",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Nimrat Grewal","Prof. Dr.","100611242","data-donation-model-for-inclusive-cardiovascular-prevention-using-the-train-health-platform-100611242",false,"NCT07238036","Data Donation Model for Inclusive Cardiovascular Prevention Using the TRAIN Health Platform","The Data Donation Model: Redefining Citizen Participation in Inclusive Cardiovascular Prevention and Care","DDM-TRAIN","Inclusion Criteria:\n\n* Adults (≥18 years)\n* Access to a smartphone, tablet, or computer with internet connection.\n* Ability to provide electronic informed consent (in Dutch or with supported translation).\n* Willingness to contribute lifestyle, health, and\u002For wearable data through the TRAIN Health Awareness Platform.\n* Optional: interest in participating in the 12-week TRAIN Heart Journey for personalised lifestyle feedback.\n\nExclusion Criteria:\n\n* Inability to provide informed consent, even with support.\n* Severe cognitive or psychiatric impairment limiting safe participation.\n* Inability to use digital devices, even with assistance.\n* Concurrent participation in another behavioural or interventional study that could interfere with data collection.",true,"ALL","18 Years",{"count":41,"type":42},450,"ESTIMATED","OBSERVATIONAL","Cardiovascular disease (CVD) is the leading cause of death in the Netherlands and worldwide. While prevention strategies have improved, many population groups, including women, individuals with a migration background, and people with lower socioeconomic status, remain underrepresented in cardiovascular research and prevention programs. As a result, current risk prediction models and lifestyle recommendations are based largely on homogeneous datasets that do not reflect real-world diversity. This structural imbalance limits the generalisability of evidence and contributes to persistent health disparities.\n\nThe Data Donation Model (DDM) aims to address this gap by introducing a citizen-led, transparent, and participatory approach to data sharing for cardiovascular prevention and health research. In this model, individuals voluntarily contribute their lifestyle, behavioural, and wearable\u002Fapp data for research while maintaining full control over consent and use. The DDM incorporates dynamic electronic consent, granular sharing options, and transparency dashboards that allow participants to view how their data contribute to ongoing research projects. This participatory design strengthens trust, autonomy, and inclusiveness in data governance.\n\nThis study evaluates the feasibility, inclusiveness, and acceptability of implementing the DDM at scale within the general population. It forms the pilot phase of a broader national data donation infrastructure coordinated by Amsterdam UMC in collaboration with the TRAIN Health Awareness Platform (technical partner) and community organisations. Approximately 450 participants will take part in this first phase, with future expansion planned up to 10,000 citizens.\n\nParticipants can connect any wearable device or health app (such as a smart ring, smartwatch, or fitness tracker) to the TRAIN platform and complete short digital questionnaires on lifestyle, sleep, stress, and wellbeing. All participants can donate data for up to 5 years, with the freedom to stop or modify consent at any time. An optional 12-week TRAIN Heart Journey provides guided feedback on physical activity, stress, and recovery patterns, but participation in this module is not required for data donation.\n\nThe main outcomes are (1) feasibility and acceptability of the DDM (recruitment, retention, adherence, and user satisfaction), (2) inclusiveness of participation across demographic groups, and (3) trust and engagement with science and data governance. Secondary outcomes include behavioural and physiological changes (activity, sleep, stress) and self-efficacy. Exploratory analyses will evaluate long-term engagement and, for consenting participants, linkage with official mortality data from Statistics Netherlands (CBS).\n\nThe findings will inform future national strategies for equitable, citizen-driven cardiovascular prevention and contribute to developing inclusive guidelines based on real-world data from diverse populations.",[46],"Cardiovascular Diseases (CVD)",[48,49,50,51,52,53,54,55,56,57,58,59,60,61],"cardiovascular prevention","data donation","citizen science","health equity","participatory research","digital health","wearable data","lifestyle monitoring","trust in science","inclusiveness","population health","prevention research","FAIR data","Open Science","NOT_YET_RECRUITING","2025-11-15",{"date":65,"type":66},"2025-11-20","ACTUAL",{"date":68,"type":42},"2026-01",{"date":70,"type":42},"2027-04-01",{"name":5,"class":6}]