[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656090":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":84,"studyPopulation":74,"armGroups":85,"interventions":101,"overallOfficials":74,"centralContacts":111,"locations":117,"responsibleParty":135,"collaborators":139,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":74,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":174,"overallStatus":120,"whyStopped":74,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"University of Eastern Finland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":74},[9,13],{"measure":10,"description":11,"timeFrame":12},"NMR-derived disease-specific 10-year risk predictions","Change from baseline in NMR-derived disease-specific 10-year risk predictions (type 2 diabetes, coronary heart disease\u002Fmyocardial infarction, stroke\u002Fcardiovascular disease, chronic kidney disease, fatty liver disease)","Baseline to 6 months",{"measure":14,"description":15,"timeFrame":16},"The World Health Organization-Five Well-Being Index (WHO-5)","Change from baseline in WHO-5 Well-Being Index. A percentage score ranging from zero to 100; zero represents worst possible mental well-being; a score of 100 represents best possible mental well-being.","Baseline to 6 months (primary); baseline to 12 months (secondary time point)",[18,22,26,29,33,36,39,42,45,48,51,54,57,60,64,68,71],{"measure":19,"description":20,"timeFrame":21},"EuroQoL 5-Dimension 5-Level (EQ-5D-5L)","EQ-5D-5L index score (obtained applying the Nordic value sets (Denmark, Norway, Sweden)) ranging from -0.285 to one; -0.285 indicates condition worse than death and one full health.","baseline and at 6 and 12 months",{"measure":23,"description":24,"timeFrame":25},"Incident diagnoses of the five target conditions","Unit of measurement is incidence of Chronic Kidney Disease, Type 2 Diabetes, Myocardial Infarction, Stroke, and Fatty Liver Disease (MASLD). Measurement tool from health registers (Eloisa´s EHR system, AvoHilmo, Hilmo).","Over at least 12 months",{"measure":27,"description":28,"timeFrame":25},"Cost-effectiveness","Incremental cost per quality-adjusted life year (QALY) gained across the three intervention arms and at the population level, estimated via microsimulation, from healthcare payer and societal perspectives",{"measure":30,"description":31,"timeFrame":32},"Work Productivity and Activity Impairment - General Health (WPAI-GH)","Four WPAI-GH subscales: absenteeism, presenteeism, overall work impairment, and activity impairment. All subscales range from zero to 100% with zero indicating no impairment and 100% indicating full impairment.","Baseline to 6 and 12 months",{"measure":34,"description":35,"timeFrame":32},"Consumer Health Activation Index (CHAI)","The ten-item CHAI score ranges from 0 to 100, with higher scores indicating greater health activation. A score of 0 indicates the lowest level of health activation, while a score of 100 indicates the highest level of health activation.",{"measure":37,"description":38,"timeFrame":32},"Vitality (TARMO)","One question with five levels. Range 1-5, 0ne indicates full vitality and five no vitality.",{"measure":40,"description":41,"timeFrame":32},"Self-rated health","One question with five levels. Range 1-5, one indicate good health and 5 indicates poor health.",{"measure":43,"description":44,"timeFrame":32},"Net Promoter Score (NPS)","NPS score is measured with a single-question survey and reported with a number ranging from -100 to +100, where a higher score is desirable.",{"measure":46,"description":47,"timeFrame":25},"New relevant prescriptions","Proportion of patients with new prescriptions for antidiabetic, antihypertensive, lipid-lowering, and renal protective drugs (Eloisa's EHR system, Kela medicine reimbursement register).",{"measure":49,"description":50,"timeFrame":25},"Work absenteeism","Number of sickness allowance days (Eloisa's EHR system, Kela register).",{"measure":52,"description":53,"timeFrame":25},"Work disability","Number of disability pension days (ETK register).",{"measure":55,"description":56,"timeFrame":25},"Hospitalization","Number of all-cause and cause-specific hospitalization days (Eloisa's EHR system, Hilmo, THL).",{"measure":58,"description":59,"timeFrame":25},"Primary care visit rates","Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)",{"measure":61,"description":62,"timeFrame":63},"Completion of the digital pathway","Indicator (0\u002F1) of digital pathway successfully initiated for the participant. Zero indicates not initiated and one successful initiation.","Baseline",{"measure":65,"description":66,"timeFrame":67},"Completion of blood sampling","Indicator (0\u002F1) of NMR blood sampling completed as planned for the participant. Zero indicates not completed and one successful completion.","Baseline and 6 months",{"measure":69,"description":70,"timeFrame":67},"Completion of risk-report delivery","Indicator (0\u002F1) of risk report successfully returned to the participant. Zero indicates no return and one successful return.",{"measure":72,"description":73,"timeFrame":63},"Correct intervention allocation relative to risk stratum","Indicator (0\u002F1) of correct intervention allocation relative to risk stratum. Zero indicates false and one correct intervention allocation.",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":78,"observationalModel":74,"timePerspective":74,"maskingInfo":79},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":80,"maskingDescription":81,"whoMasked":82},"SINGLE","None (Open Label). Blinding of participants and intervention providers to allocation is not feasible given the nature of digital lifestyle interventions.\n\n* The biomarker laboratory (Nightingale Health) is blinded to intervention allocation throughout all NMR analyses\n* Health-register data linkage is performed by Findata, independent of trial conduct\n* The primary statistical analysis is conducted by the independent trial statistician per a pre-specified, locked Statistical Analysis Plan\n* Patient-reported outcomes are self-completed, with no assessor involvement",[83],"CARE_PROVIDER","The study addresses an evidence gap: no published pragmatic, randomized trial has directly compared digital lifestyle intervention platforms in a population prospectively risk-stratified through NMR metabolomics in a real-world public-sector setting. PREMAP combines a prospective, population-based cohort (all enrolled participants, followed regardless of risk group) with an embedded pragmatic, open-label, three-arm randomized controlled trial restricted to participants classified as moderate or high multi-disease risk. The non-randomized low-risk group receives its risk result and general health information and is followed as a naturalistic reference group; withholding a risk result or randomizing this group to an active digital intervention was judged neither scientifically nor ethically justified.\n\nAt the population cohort level, the study evaluates change from baseline to 6 months in the five NMR-derived disease-specific risk predictions and in the WHO-5 wellbeing score across all enrolled participants. Within the embedded randomised substudy, the three digital health arms are compared head-to-head on the same two outcome domains at 6 months, adjusting for guideline-directed medical therapy status and relevant covariates. Secondary objectives include patient-reported outcomes (health-related quality of life, work productivity, health activation, life satisfaction), clinical and health-register-based outcomes (incident diagnoses, new prescriptions, hospitalization, sickness absence) over at least 12 months, and a health economic evaluation using patient-level Monte Carlo microsimulation to estimate cost per quality-adjusted life year (QALY) gained, from both healthcare payer and societal perspectives.",[86,92,96],{"label":87,"type":88,"description":89,"interventionNames":90},"Arm 1: BitHabit","EXPERIMENTAL","Digital, self-directed lifestyle behavior-change smartphone application based on habit-formation and behavioral-economics principles. Provides personalized, small, achievable habit suggestions targeting physical activity, nutrition, sleep, stress management and recovery. Active engagement up to 6 months from randomization; app access continues to 12 months.",[91],"Behavioral: Digital health interventions",{"label":93,"type":88,"description":94,"interventionNames":95},"Arm 2: Onnikka","Digital lifestyle coaching programme grounded in cognitive behavioral therapy and acceptance and commitment therapy, focused on sustainable weight management and metabolic risk reduction through structured programme modules, automated check-ins and optional peer support. Active engagement up to 12 months from randomization.",[91],{"label":97,"type":98,"description":99,"interventionNames":100},"Arm 3: Oma Eloisa","ACTIVE_COMPARATOR","Structured digital self-care pathway based on national clinical guidelines, providing lifestyle information, guidance and self-monitoring tools without personalized coaching or professional support. Represents the current standard of digital support available in the Eloisa region and is used as the comparator arm; low-risk participants also use this pathway on a non-randomized basis. Continuous access throughout the follow-up period (up to 12 months).",[91],[102],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"BEHAVIORAL","Digital health interventions","Arm 1: BitHabit digital lifestyle app (12 months); Arm 2: Onnikka digital lifestyle coaching (12 months); Arm 3: Oma Eloisa digital self-care pathway (comparator). High-risk participants additionally receive physician consultation + Guideline-Directed Medical Treatment (GDMT) optimisation in the high-risk arm.",[87,93,97],[108,109,110],"BitHabit digital lifestyle app","Onnikka digital lifestyle coachingy","Oma Eloisa digital self-care pathway",[112],{"name":113,"role":114,"phone":115,"phoneExt":74,"email":116},"Janne Martikainen, PhD, Professor","CONTACT","+3583552600","janne.martikainen@uef.fi",[118],{"facility":119,"status":120,"city":121,"state":74,"zip":74,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"Wellbeing Services County of South Savo (Eloisa) (provide social and healthcare services and emergency services in the Enonkoski, Hirvensalmi, Juva, Kangasniemi, Mikkeli, Mäntyharju, Pieksämäki, Puumala, Rantasalmi, Savonlinna ja Sulkava)","RECRUITING","Savonlinna","Finland","FI",{"type":125,"coordinates":126},"Point",[127,128],28.87999,61.8699,{"lat":128,"lon":127},[131],{"name":132,"role":114,"phone":133,"phoneExt":74,"email":134},"Anna-Sofia Simula","+35840 1294676","anna-sofia.simula@etelasavonha.fi",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"PRINCIPAL_INVESTIGATOR","Janne Martikainen","PhD, Professor",[140,142,145],{"name":141,"class":6},"Sitra, the Finnish Innovation Fund",{"name":143,"class":144},"Wellbeing Services County of South Savo (Eloisa)","UNKNOWN",{"name":146,"class":144},"Nightingale Health Plc","100656090","nmr-metabolomics-based-risk-assessment-and-stratified-digital-health-interventions-in-middle-aged-adults-premap-100656090",false,"NCT07820800","NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP)","Effectiveness and Cost-Effectiveness of NMR Metabolomics-Based Risk Assessment and Stratified Preventive Digital and Guideline-Directed Interventions in a Middle-Aged Population: A Population Cohort Study With an Embedded Pragmatic Randomised Trial and Health Economic Evaluation","PREMAP","Inclusion Criteria:\n\n* Permanent resident of the Eloisa Wellbeing Services County (South Savo, Finland), or has selected Eloisa primary health care as their primary public care provider\n* Turning 45, 50, or 55 years of age during calendar year 2026\n* NMR metabolomics-based risk assessment result classified as low, moderate, or high multi-disease risk\n* Able to provide written informed consent digitally\n* Able to use a smartphone, tablet, or computer for digital application access\n* Resident of Finland with a Finnish personal identity code (required for health register linkage)\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding\n* Incarcerated or under forensic psychiatric care\n* Significantly impaired capacity for self-determination\n* Insufficient proficiency in Finnish to provide informed consent and complete study procedures\n* No Finnish personal identity code",true,"ALL","45 Years","55 Years",{"count":160,"type":161},1400,"ESTIMATED","INTERVENTIONAL",[164],"NA","PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease\u002Fmyocardial infarction, stroke\u002Fcardiovascular disease, chronic kidney disease, and fatty liver disease), alongside a mental wellbeing assessment (WHO-5 Well-Being Index). Based on this risk profile, participants are classified as low, moderate, or high multi-disease risk. Participants at moderate or high risk are individually randomized in a 1:1:1 ratio to one of three digital health interventions for up to 12 months: a habit-based lifestyle application (BitHabit), a structured digital lifestyle coaching programme (Onnikka), or a guideline-based digital self-care pathway (Oma Eloisa, comparator). Participants at high risk additionally receive a physician consultation and optimization of guideline-directed medical therapy. All participants, including the non-randomized low-risk group, are followed prospectively at baseline, 6 months, and 12 months. The study evaluates whether early risk identification and risk-stratified digital interventions reduce future disease risk and improve wellbeing and estimates the cost-effectiveness of the overall approach for the Finnish healthcare system.",[167,168,169,170,171,172,173],"Type 2 Diabetes","Coronary Heart Disease","Myocardial Infarction","Cerebrovascular Disease","Stroke","Chronic Kidney Disease","Fatty Liver Disease",[175,176,177,178,179,180,181,182],"cardio-renal-metabolic risk","preventive medicine","metabolomics","digital health intervention","risk stratification","primary prevention","wellbeing","health economics","2026-10-05",{"date":185,"type":186},"2026-10-06","ACTUAL",{"date":188,"type":161},"2026-09",{"date":190,"type":161},"2028-03",{"name":5,"class":6},1]