NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP) (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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Janne Martikainen, PhD, Professor
- Telefonnummer: +3583552600
- E-Mail: janne.martikainen@uef.fi
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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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.
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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.
Andere Namen:
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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.
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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.
Andere Namen:
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Aktiver Komparator: 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).
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
NMR-derived disease-specific 10-year risk predictions
Zeitfenster: 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)
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Baseline to 6 months
|
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The World Health Organization-Five Well-Being Index (WHO-5)
Zeitfenster: Baseline to 6 months (primary); baseline to 12 months (secondary time point)
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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.
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Baseline to 6 months (primary); baseline to 12 months (secondary time point)
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Zeitfenster: 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
|
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Incident diagnoses of the five target conditions
Zeitfenster: 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).
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Over at least 12 months
|
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Cost-effectiveness
Zeitfenster: 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
|
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Work Productivity and Activity Impairment - General Health (WPAI-GH)
Zeitfenster: 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)
Zeitfenster: 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.
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Baseline to 6 and 12 months
|
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Vitality (TARMO)
Zeitfenster: Baseline to 6 and 12 months
|
One question with five levels.
Range 1-5, 0ne indicates full vitality and five no vitality.
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Baseline to 6 and 12 months
|
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Self-rated health
Zeitfenster: Baseline to 6 and 12 months
|
One question with five levels.
Range 1-5, one indicate good health and 5 indicates poor health.
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Baseline to 6 and 12 months
|
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Net Promoter Score (NPS)
Zeitfenster: 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.
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Baseline to 6 and 12 months
|
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New relevant prescriptions
Zeitfenster: 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).
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Over at least 12 months
|
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Work absenteeism
Zeitfenster: Over at least 12 months
|
Number of sickness allowance days (Eloisa's EHR system, Kela register).
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Over at least 12 months
|
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Work disability
Zeitfenster: Over at least 12 months
|
Number of disability pension days (ETK register).
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Over at least 12 months
|
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Hospitalization
Zeitfenster: 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
Zeitfenster: Over at least 12 months
|
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)
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Over at least 12 months
|
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Completion of the digital pathway
Zeitfenster: Baseline
|
Indicator (0/1) of digital pathway successfully initiated for the participant.
Zero indicates not initiated and one successful initiation.
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Baseline
|
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Completion of blood sampling
Zeitfenster: 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.
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Baseline and 6 months
|
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Completion of risk-report delivery
Zeitfenster: Baseline and 6 months
|
Indicator (0/1) of risk report successfully returned to the participant.
Zero indicates no return and one successful return.
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Baseline and 6 months
|
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Correct intervention allocation relative to risk stratum
Zeitfenster: Baseline
|
Indicator (0/1) of correct intervention allocation relative to risk stratum.
Zero indicates false and one correct intervention allocation.
|
Baseline
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Erkrankungen des endokrinen Systems
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Herzkrankheiten
- Chronische Erkrankung
- Krankheitsattribute
- Stoffwechselerkrankungen
- Erkrankungen des Verdauungssystems
- Störungen des Glukosestoffwechsels
- Diabetes Mellitus
- Infarkt
- Nekrose
- Leberkrankheiten
- Niereninsuffizienz
- Myokardischämie
- Ischämie
- Fettleber
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Streicheln
- Diabetes mellitus, Typ 2
- Nicht alkoholische Fettleber
- Niereninsuffizienz, chronisch
- Koronare Krankheit
- Zerebrovaskuläre Erkrankungen
- Herzinfarkt
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 189/2026
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