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.
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. At 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,400
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.
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)
Time frame: Baseline to 6 months
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.
Time frame: Baseline to 6 months (primary); baseline to 12 months (secondary time point)
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.
Time frame: baseline and at 6 and 12 months
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).
Time frame: Over at least 12 months
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
Time frame: Over at least 12 months
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.
Time frame: Baseline to 6 and 12 months
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.
Time frame: Baseline to 6 and 12 months
Vitality (TARMO)
One question with five levels. Range 1-5, 0ne indicates full vitality and five no vitality.
Time frame: Baseline to 6 and 12 months
Self-rated health
One question with five levels. Range 1-5, one indicate good health and 5 indicates poor health.
Time frame: Baseline to 6 and 12 months
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.
Time frame: Baseline to 6 and 12 months
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).
Time frame: Over at least 12 months
Work absenteeism
Number of sickness allowance days (Eloisa's EHR system, Kela register).
Time frame: Over at least 12 months
Work disability
Number of disability pension days (ETK register).
Time frame: Over at least 12 months
Hospitalization
Number of all-cause and cause-specific hospitalization days (Eloisa's EHR system, Hilmo, THL).
Time frame: Over at least 12 months
Primary care visit rates
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)
Time frame: Over at least 12 months
Completion of the digital pathway
Indicator (0/1) of digital pathway successfully initiated for the participant. Zero indicates not initiated and one successful initiation.
Time frame: Baseline
Completion of blood sampling
Indicator (0/1) of NMR blood sampling completed as planned for the participant. Zero indicates not completed and one successful completion.
Time frame: Baseline and 6 months
Completion of risk-report delivery
Indicator (0/1) of risk report successfully returned to the participant. Zero indicates no return and one successful return.
Time frame: Baseline and 6 months
Correct intervention allocation relative to risk stratum
Indicator (0/1) of correct intervention allocation relative to risk stratum. Zero indicates false and one correct intervention allocation.
Time frame: Baseline
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