NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP)

Cerebrovascular Disease, Chronic Kidney Disease, Coronary Heart Disease, Fatty Liver Disease, Myocardial Infarction, Stroke, Type 2 Diabetes

cardio-renal-metabolic risk, preventive medicine, metabolomics, digital health intervention, risk stratification, primary prevention, wellbeing, health economics

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.

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