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

NCT07820800 | Not Yet Recruiting DMC

• 1 other identifier: 189/2026
• Study Type: interventional
• Target: 1,400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Baseline to 6 months (primary); baseline to 12 months (secondary time point)

Secondary Outcomes (17)

• EuroQoL 5-Dimension 5-Level (EQ-5D-5L)

  baseline and at 6 and 12 months

• Incident diagnoses of the five target conditions

  Over at least 12 months

• Cost-effectiveness

  Over at least 12 months

• Work Productivity and Activity Impairment - General Health (WPAI-GH)

  Baseline to 6 and 12 months

• Consumer Health Activation Index (CHAI)

  Baseline to 6 and 12 months

Study Arms (3)

Arm 1: BitHabit

EXPERIMENTAL

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 2: Onnikka

EXPERIMENTAL

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 3: Oma Eloisa

ACTIVE COMPARATOR

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

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.

Also known as: BitHabit digital lifestyle app, Onnikka digital lifestyle coachingy, Oma Eloisa digital self-care pathway

Arm 1: BitHabit; Arm 2: Onnikka; Arm 3: Oma Eloisa

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead
• Sitra, the Finnish Innovation Fund: collaborator
• Wellbeing Services County of South Savo (Eloisa): collaborator
• Nightingale Health Plc: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Disease; Myocardial Infarction; Cerebrovascular Disorders; Stroke; Renal Insufficiency, Chronic; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Janne Martikainen, PhD, Professor

CONTACT

+3583552600; janne.martikainen@uef.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: None (Open Label). Blinding of participants and intervention providers to allocation is not feasible given the nature of digital lifestyle interventions. * The biomarker laboratory (Nightingale Health) is blinded to intervention allocation throughout all NMR analyses * Health-register data linkage is performed by Findata, independent of trial conduct * The primary statistical analysis is conducted by the independent trial statistician per a pre-specified, locked Statistical Analysis Plan * Patient-reported outcomes are self-completed, with no assessor involvement
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share