An interventional study of Digital health interventions in Type 2 Diabetes, Coronary Heart Disease and Myocardial Infarction, sponsored by University of Eastern Finland. Recruiting at 1 site in Finland. Open to participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Eastern Finland · Not applicable, Interventional, and Prevention
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Digital, self-directed lifestyle behavior-change smartphone application based on habit-formation and behavioral-economics principles. Provides personalized, small, achievable habit suggestions targeting physical activity, nutrition, sleep, stress management and recovery. Active engagement up to 6 months from randomization; app access continues to 12 months.
Behavioral: Digital health interventions
Digital lifestyle coaching programme grounded in cognitive behavioral therapy and acceptance and commitment therapy, focused on sustainable weight management and metabolic risk reduction through structured programme modules, automated check-ins and optional peer support. Active engagement up to 12 months from randomization.
Behavioral: Digital health interventions
Structured digital self-care pathway based on national clinical guidelines, providing lifestyle information, guidance and self-monitoring tools without personalized coaching or professional support. Represents the current standard of digital support available in the Eloisa region and is used as the comparator arm; low-risk participants also use this pathway on a non-randomized basis. Continuous access throughout the follow-up period (up to 12 months).
Behavioral: Digital health interventions
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.
Also known as: BitHabit digital lifestyle app, Onnikka digital lifestyle coachingy, Oma Eloisa digital self-care pathway
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
Plan to share: No — Plan to Share Individual Participant Data (IPD): Case-by-case. The full trial protocol (current version) will be deposited on the trial registry and in the Finnish national research data storage service (IDA) at the time of registration. Requests for data sharing beyond the deposited protocol will be considered by the Trial Steering Committee on a case-by-case basis, subject to GDPR compliance and Findata regulations. Results and publications: all primary and secondary results are intended for peer-reviewed open-access publication (CC BY 4.0), following ICMJE authorship criteria.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Eastern Finland