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

Sponsor: University of Eastern Finland • ClinicalTrials.gov ID: NCT07820800

Registry updated: 2026-10-06

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Description

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.

Interventions

Digital health interventions (Behavioral)
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.

Eligibility criteria

Inclusion Criteria: * 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 * Able to use a smartphone, tablet, or computer for digital application access * Resident of Finland with a Finnish personal identity code (required for health register linkage) Exclusion Criteria: * 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 * No Finnish personal identity code

Conditions

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

Locations

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) — Savonlinna, Finland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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