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

Study acronym: PREMAP
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07820800
Lead Sponsor University of Eastern Finland
Collaborators: Sitra, the Finnish Innovation Fund, Wellbeing Services County of South Savo (Eloisa), Nightingale Health Plc
Conditions Type 2 Diabetes, Coronary Heart Disease, Myocardial Infarction, Cerebrovascular Disease, Stroke, Chronic Kidney Disease, Fatty Liver Disease
Enrollment 1,400 participants
Start Date 2026-09
Primary Completion 2027-09 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-15