Clinical trial NCT03650127: Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study
Official title: Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Type 2 Diabetes
Deep Vein Thrombosis
Keywords: Genetic risk score
metabolic risk score
health promotion
web-based
intervention
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
name: Institute for Molecular Medicine
First posted: 2018-08-28
Enrollment: 3449
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population of FinHealth 2017 -study represent the general population of Finland. All participants are over 18 years of age and have been selected randomly from the population registry. All FinHealth 2017 participants with DNA sample and permission for a re-contact were invited to P5.fi study.

Brief summary: P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants.

The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.


Eligibility criteria: Inclusion Criteria:

- Only participants of FinHealth 2017 -study are eligible for the study

Exclusion Criteria:

- Participants not part of FinHealth 2017 -study are not eligible

Primary outcomes:
measure: Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis
timeFrame: Measure is assessed after a year from the start of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Institute of Health and Welfare
state: Uusimaa
Study officials:
affiliation: National Institute of Health and Welfare
name: Markus Perola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: