NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP) (PREMAP)
2026년 9월 10일 업데이트: Janne Martikainen, University of Eastern Finland
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.
연구 개요
상태
아직 모집하지 않음
개입 / 치료
상세 설명
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.
연구 유형
중재적
등록 (추정된)
1400
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Janne Martikainen, PhD, Professor
- 전화번호: +3583552600
- 이메일: janne.martikainen@uef.fi
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
NMR-derived disease-specific 10-year risk predictions
기간: 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)
|
Baseline to 6 months
|
|
The World Health Organization-Five Well-Being Index (WHO-5)
기간: 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.
|
Baseline to 6 months (primary); baseline to 12 months (secondary time point)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
기간: 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
|
|
Incident diagnoses of the five target conditions
기간: 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).
|
Over at least 12 months
|
|
Cost-effectiveness
기간: 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
|
|
Work Productivity and Activity Impairment - General Health (WPAI-GH)
기간: 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)
기간: 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.
|
Baseline to 6 and 12 months
|
|
Vitality (TARMO)
기간: Baseline to 6 and 12 months
|
One question with five levels.
Range 1-5, 0ne indicates full vitality and five no vitality.
|
Baseline to 6 and 12 months
|
|
Self-rated health
기간: Baseline to 6 and 12 months
|
One question with five levels.
Range 1-5, one indicate good health and 5 indicates poor health.
|
Baseline to 6 and 12 months
|
|
Net Promoter Score (NPS)
기간: 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.
|
Baseline to 6 and 12 months
|
|
New relevant prescriptions
기간: 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).
|
Over at least 12 months
|
|
Work absenteeism
기간: Over at least 12 months
|
Number of sickness allowance days (Eloisa's EHR system, Kela register).
|
Over at least 12 months
|
|
Work disability
기간: Over at least 12 months
|
Number of disability pension days (ETK register).
|
Over at least 12 months
|
|
Hospitalization
기간: 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
기간: Over at least 12 months
|
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)
|
Over at least 12 months
|
|
Completion of the digital pathway
기간: Baseline
|
Indicator (0/1) of digital pathway successfully initiated for the participant.
Zero indicates not initiated and one successful initiation.
|
Baseline
|
|
Completion of blood sampling
기간: 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.
|
Baseline and 6 months
|
|
Completion of risk-report delivery
기간: Baseline and 6 months
|
Indicator (0/1) of risk report successfully returned to the participant.
Zero indicates no return and one successful return.
|
Baseline and 6 months
|
|
Correct intervention allocation relative to risk stratum
기간: Baseline
|
Indicator (0/1) of correct intervention allocation relative to risk stratum.
Zero indicates false and one correct intervention allocation.
|
Baseline
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 9월 1일
연구 완료 (추정된)
2028년 3월 1일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 10일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 189/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .