No phaseRecruiting
NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP)
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
- Sponsor
- University of Eastern Finland (Academic or other)
- Enrolment
- 1,400 planned
- Conditions
- Type 2 Diabetes; Coronary Heart Disease; Myocardial Infarction; Cerebrovascular Disease; Stroke; Chronic Kidney Disease; Fatty Liver Disease
- Interventions
- Digital health interventions
- Ages
- adults
- Registry
- NCT07820800
Full record on ClinicalTrials.gov
From the registry
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,…
Primary outcomes
- NMR-derived disease-specific 10-year risk predictions
- The World Health Organization-Five Well-Being Index (WHO-5)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started