About this trial
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/myocardial infarction, stroke/cardiovascular 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Permanent resident of the Eloisa Wellbeing Services County (South Savo, Finland), or has selected Eloisa primary health care as their primary public care provider
Turning 45, 50, or 55 years of age during calendar year 2026
NMR metabolomics-based risk assessment result classified as low, moderate, or high multi-disease risk
Able to provide written informed consent digitally
Disqualifiers
Currently pregnant or breastfeeding
Incarcerated or under forensic psychiatric care
Significantly impaired capacity for self-determination
Insufficient proficiency in Finnish to provide informed consent and complete study procedures
Trial design
Parallel
Treatments tested in this trial
Digital health interventions
BehavioralArm 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.
Treatment groups
Trial outcomes
Primary outcomes
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/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, fatty liver disease)
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.
Secondary outcomes
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.
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).
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
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.
Sponsors and contacts
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University of Eastern Finland
Lead sponsor
Sitra, the Finnish Innovation Fund
Collaborator
Wellbeing Services County of South Savo (Eloisa)
Collaborator
Nightingale Health Plc
Collaborator