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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,400
- 主要终点
- NMR-derived disease-specific 10-year risk predictions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
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
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Digital health interventions (Behavioral)
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.
干预措施: Digital health interventions (Behavioral)
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).
干预措施: Digital health interventions (Behavioral)
结局指标
主要结局
NMR-derived disease-specific 10-year risk predictions
时间窗: 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)
The World Health Organization-Five Well-Being Index (WHO-5)
时间窗: 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.
次要结局
- 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)
- Vitality (TARMO)(Baseline to 6 and 12 months)
- Self-rated health(Baseline to 6 and 12 months)
- Net Promoter Score (NPS)(Baseline to 6 and 12 months)
- New relevant prescriptions(Over at least 12 months)
- Work absenteeism(Over at least 12 months)
- Work disability(Over at least 12 months)
- Hospitalization(Over at least 12 months)
- Primary care visit rates(Over at least 12 months)
- Completion of the digital pathway(Baseline)
- Completion of blood sampling(Baseline and 6 months)
- Completion of risk-report delivery(Baseline and 6 months)
- Correct intervention allocation relative to risk stratum(Baseline)
研究者
Janne Martikainen
PhD, Professor
University of Eastern Finland