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Active Not Recruiting NCT05603663

High Polygenic Risk and Health Behavior

Conditions: Cardiovascular Diseases

Sex: All
Ages: 25 Years – 44 Years
Phase: NA
Enrollment: 1540
Sponsor: University of Tartu

Location: Estonia

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.

Eligibility Criteria

Inclusion Criteria:Body mass index 25-29.99High polygenic risk for cardiovascular disease confirmedWilling and able to participate in the trialInformed consent providedExclusion Criteria:Diagnosis of ischemic heart disease (I20-25)Diagnosis of stroke (I60-64, I69, G45)Diagnosis of peripheral vascular occlusion (I65-66, I67.2, I70, I73.9)Diagnosis of diabetes (E10-14)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05603663). StuddyBuddy aggregates publicly available trial information.