High Polygenic Risk and Health Behavior

Summary

The goal of this clinical trial is to evaluate the impact of awareness of high polygenic risk for CVD on health behavior among young overweight adults. We want to evaluate the impact of awareness of high polygenic risk for CVD on body mass index within 12 months, the impact of awareness of high polygenic risk for CVD on other health indicators (physical activity, systolic blood pressure, cholesterol and triglyceride levels, smoking, waist circumference, CVD risk score), and assess the cost-effectiveness of informing people about the high polygenic risk for CVD.

The trial will be conducted in a primary care setting, for which the high genetic-risk subjects will be invited to visit their family physician. In the course of the first visit, the family physician will assess the participant's health status and will counsel the participant on healthy choices for increasing their level of physical activity and losing weight. If necessary, the family physician will start treatment to lower the participant's blood pressure or cholesterol following current treatment guidelines. The participants in the intervention group will be informed of their high polygenic risk for CVD at the start of the study, while the control subjects at the end of the study. There will be three study visits at 6-month intervals. Between visits, the participants will receive reminders via a mobile health application to change their health behavior. At the end of the trial (month 12), the health indicators of the participants will be assessed and compared between the three trial groups. If a significant difference in BMI is found, it will presumably be related to the fact of learning of the high genetic risk, in which case the use of genetic data in primary prevention may be considered effective.

Conditions

• Cardiovascular Diseases

Interventions

GENETIC

Informing study subjects about their high CVD polygenic risk score

During a visit, the family physician will announce the value of the subject's polygenic risk for CVD (either at the start or end of the trial, depending on the group) and discuss what it means, calculate the subject's overall risk for CVD using the Kardiokompass tool, advise the subject on weight loss and physical activity, and, if necessary, commence preventive treatment. Between visits, a mobile application will be utilized to collect data about the subjects' level of physical activity and body weight as well as to send reminders to the subjects every two weeks regarding exercise and healthy lifestyle choices.

Sponsors & Collaborators

• University of Helsinki

  collaborator OTHER

• The Estonian Health Insurance Fund

  collaborator UNKNOWN

• University of Tartu

  lead OTHER

Principal Investigators

• Mikk JÜRISSON, PhD · University of Tartu

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

44 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-20

Primary Completion

2024-01-20

Completion

2024-01-20

Countries

• Estonia

Study Locations