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
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Janne Martikainen, PhD, Professor
- 電話番号：+3583552600
- メール：janne.martikainen@uef.fi
研究場所
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Savonlinna、フィンランド
- 募集
- Wellbeing Services County of South Savo (Eloisa) (provide social and healthcare services and emergency services in the Enonkoski, Hirvensalmi, Juva, Kangasniemi, Mikkeli, Mäntyharju, Pieksämäki, Puumala, Rantasalmi, Savonlinna ja Sulkava)
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コンタクト：
- Anna-Sofia Simula
- 電話番号：+35840 1294676
- メール：anna-sofia.simula@etelasavonha.fi
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：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. |
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.
他の名前：
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実験的：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. |
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.
他の名前：
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アクティブコンパレータ：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). |
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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NMR-derived disease-specific 10-year risk predictions
時間枠：Baseline to 6 months
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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
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The World Health Organization-Five Well-Being Index (WHO-5)
時間枠：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. |
Baseline to 6 months (primary); baseline to 12 months (secondary time point)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
時間枠：baseline and at 6 and 12 months
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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
時間枠：Over at least 12 months
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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). |
Over at least 12 months
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Cost-effectiveness
時間枠：Over at least 12 months
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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)
時間枠：Baseline to 6 and 12 months
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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
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Consumer Health Activation Index (CHAI)
時間枠：Baseline to 6 and 12 months
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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. |
Baseline to 6 and 12 months
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Vitality (TARMO)
時間枠：Baseline to 6 and 12 months
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One question with five levels. Range 1-5, 0ne indicates full vitality and five no vitality. |
Baseline to 6 and 12 months
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Self-rated health
時間枠：Baseline to 6 and 12 months
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One question with five levels. Range 1-5, one indicate good health and 5 indicates poor health. |
Baseline to 6 and 12 months
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Net Promoter Score (NPS)
時間枠：Baseline to 6 and 12 months
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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. |
Baseline to 6 and 12 months
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New relevant prescriptions
時間枠：Over at least 12 months
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Proportion of patients with new prescriptions for antidiabetic, antihypertensive, lipid-lowering, and renal protective drugs (Eloisa's EHR system, Kela medicine reimbursement register). |
Over at least 12 months
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Work absenteeism
時間枠：Over at least 12 months
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Number of sickness allowance days (Eloisa's EHR system, Kela register). |
Over at least 12 months
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Work disability
時間枠：Over at least 12 months
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Number of disability pension days (ETK register). |
Over at least 12 months
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Hospitalization
時間枠：Over at least 12 months
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Number of all-cause and cause-specific hospitalization days (Eloisa's EHR system, Hilmo, THL). |
Over at least 12 months
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Primary care visit rates
時間枠：Over at least 12 months
|
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL) |
Over at least 12 months
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Completion of the digital pathway
時間枠：Baseline
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Indicator (0/1) of digital pathway successfully initiated for the participant. Zero indicates not initiated and one successful initiation. |
Baseline
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Completion of blood sampling
時間枠：Baseline and 6 months
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Indicator (0/1) of NMR blood sampling completed as planned for the participant. Zero indicates not completed and one successful completion. |
Baseline and 6 months
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Completion of risk-report delivery
時間枠：Baseline and 6 months
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Indicator (0/1) of risk report successfully returned to the participant. Zero indicates no return and one successful return. |
Baseline and 6 months
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Correct intervention allocation relative to risk stratum
時間枠：Baseline
|
Indicator (0/1) of correct intervention allocation relative to risk stratum. Zero indicates false and one correct intervention allocation. |
Baseline
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協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 189/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Plan to Share Individual Participant Data (IPD): Case-by-case. The full trial protocol (current version) will be deposited on the trial registry and in the Finnish national research data storage service (IDA) at the time of registration. Requests for data sharing beyond the deposited protocol will be considered by the Trial Steering Committee on a case-by-case basis, subject to GDPR compliance and Findata regulations. Results and publications: all primary and secondary results are intended for peer-reviewed open-access publication (CC BY 4.0), following ICMJE authorship criteria.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。