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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-55
SponsorUniversity of Eastern Finland

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,400 Participants
are divided into 3 treatment groups
Group A: Arm 1: BitHabitExperimental treatment 1 intervention
Group B: Arm 2: OnnikkaExperimental treatment 1 intervention
Group C: Arm 3: Oma EloisaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Eastern Finland

Lead sponsor

Sitra, the Finnish Innovation Fund

Collaborator

Wellbeing Services County of South Savo (Eloisa)

Collaborator

Nightingale Health Plc

Collaborator