High Polygenic Risk and Health Behavior

NCT05603663 | Unknown

• 1 other identifier: Grant #101016775
• Study Type: interventional
• Target: 1,540
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI)

  The difference in mean BMI between study groups. Weight and height will be combined to report BMI in kg/m2

  12 months

Secondary Outcomes (6)

• Systolic blood pressure

  12 months

• Total Cholesterol

  12 months

• Waist circumference

  12 months

• Smoking prevalence

  12 months

• Physical activity

  12 months

Study Arms (3)

Intervention arm

EXPERIMENTAL

Young (25-44 years) overweight adults with high (top 20%) CVD PRS. The participants will be informed about their high PRS at the start of the study, calculated the overall CVD risk, and provided counseling and treatment of hypertension and/or high cholesterol if appropriate.

Genetic: Informing study subjects about their high CVD polygenic risk score

Control group #1

NO INTERVENTION

Young (25-44 years) overweight adults with high (top 20%) CVD PRS. The participants will be informed about the overall CVD risk and provided counseling and treatment of hypertension and/or high cholesterol if appropriate. The participants will be informed about their high PRS only at the end of the study.

Control group #2

NO INTERVENTION

Young (25-44 years) overweight adults with low (bottom 20%) CVD PRS. The participants will be informed about the overall CVD risk and provided counseling and treatment of hypertension and/or high cholesterol if appropriate. The participants will be informed about their low PRS only at the end of the study.

Interventions

Informing study subjects about their high CVD polygenic risk score GENETIC

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.

Intervention arm

Eligibility Criteria

• Age: 25 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index 25-29.99
• High polygenic risk for cardiovascular disease confirmed
• Willing and able to participate in the trial
• Informed consent provided

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Tartu: lead
• University of Helsinki: collaborator
• The Estonian Health Insurance Fund: collaborator

Study Sites (1)

Institute of Family Medicine and Public Health, University of Tartu

Tartu, 50408, Estonia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mikk JÜRISSON, PhD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 3, 2022
• Study Start: April 20, 2022
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)