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

September 10, 2026 updated by: Janne Martikainen, University of Eastern Finland

Effectiveness and Cost-Effectiveness of NMR Metabolomics-Based Risk Assessment and Stratified Preventive Digital and Guideline-Directed Interventions in a Middle-Aged Population: A Population Cohort Study With an Embedded Pragmatic Randomised Trial and Health Economic Evaluation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: BitHabit
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
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.
Other Names:
  • BitHabit digital lifestyle app
  • Onnikka digital lifestyle coachingy
  • Oma Eloisa digital self-care pathway
Experimental: Arm 2: Onnikka
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
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.
Other Names:
  • BitHabit digital lifestyle app
  • Onnikka digital lifestyle coachingy
  • Oma Eloisa digital self-care pathway
Active Comparator: Arm 3: Oma Eloisa
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.
Other Names:
  • BitHabit digital lifestyle app
  • Onnikka digital lifestyle coachingy
  • Oma Eloisa digital self-care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NMR-derived disease-specific 10-year risk predictions
Time Frame: Baseline to 6 months
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)
Baseline to 6 months
The World Health Organization-Five Well-Being Index (WHO-5)
Time Frame: Baseline to 6 months (primary); baseline to 12 months (secondary time point)
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.
Baseline to 6 months (primary); baseline to 12 months (secondary time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: baseline and at 6 and 12 months
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.
baseline and at 6 and 12 months
Incident diagnoses of the five target conditions
Time Frame: Over at least 12 months
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).
Over at least 12 months
Cost-effectiveness
Time Frame: Over at least 12 months
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
Over at least 12 months
Work Productivity and Activity Impairment - General Health (WPAI-GH)
Time Frame: Baseline to 6 and 12 months
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.
Baseline to 6 and 12 months
Consumer Health Activation Index (CHAI)
Time Frame: Baseline to 6 and 12 months
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.
Baseline to 6 and 12 months
Vitality (TARMO)
Time Frame: Baseline to 6 and 12 months
One question with five levels. Range 1-5, 0ne indicates full vitality and five no vitality.
Baseline to 6 and 12 months
Self-rated health
Time Frame: Baseline to 6 and 12 months
One question with five levels. Range 1-5, one indicate good health and 5 indicates poor health.
Baseline to 6 and 12 months
Net Promoter Score (NPS)
Time Frame: Baseline to 6 and 12 months
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.
Baseline to 6 and 12 months
New relevant prescriptions
Time Frame: Over at least 12 months
Proportion of patients with new prescriptions for antidiabetic, antihypertensive, lipid-lowering, and renal protective drugs (Eloisa's EHR system, Kela medicine reimbursement register).
Over at least 12 months
Work absenteeism
Time Frame: Over at least 12 months
Number of sickness allowance days (Eloisa's EHR system, Kela register).
Over at least 12 months
Work disability
Time Frame: Over at least 12 months
Number of disability pension days (ETK register).
Over at least 12 months
Hospitalization
Time Frame: Over at least 12 months
Number of all-cause and cause-specific hospitalization days (Eloisa's EHR system, Hilmo, THL).
Over at least 12 months
Primary care visit rates
Time Frame: Over at least 12 months
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)
Over at least 12 months
Completion of the digital pathway
Time Frame: Baseline
Indicator (0/1) of digital pathway successfully initiated for the participant. Zero indicates not initiated and one successful initiation.
Baseline
Completion of blood sampling
Time Frame: Baseline and 6 months
Indicator (0/1) of NMR blood sampling completed as planned for the participant. Zero indicates not completed and one successful completion.
Baseline and 6 months
Completion of risk-report delivery
Time Frame: Baseline and 6 months
Indicator (0/1) of risk report successfully returned to the participant. Zero indicates no return and one successful return.
Baseline and 6 months
Correct intervention allocation relative to risk stratum
Time Frame: Baseline
Indicator (0/1) of correct intervention allocation relative to risk stratum. Zero indicates false and one correct intervention allocation.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Collaborators

Sitra, the Finnish Innovation Fund
Wellbeing Services County of South Savo (Eloisa)
Nightingale Health Plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 189/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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