Summary
This randomized clinical trial aims to assess the efficacy of disseminating polygenic risk score (PRS) results for systolic blood pressure (SBP) on SBP control, healthy lifestyle adherence, and cardiometabolic profiles in young and middle-aged US adults with hypertension and poor cardiovascular health.
What they want
The study will enroll and randomize 300 adults (aged 18-55 years, 50% females) into two arms: SBP PRS disclosure (receiving SBP PRS results and genomic counseling) or routine care. Participants in both arms will receive educational materials on hypertension control at baseline. The SBP PRS disclosure arm will receive additional genomic counseling during 3-monthly in-person follow-up visits. The primary aim is to assess the change in 24-hour mean SBP at 1 year between the two study arms. Secondary aims include assessing changes in diet (Healthy Eating Index), physical activity (actigraphy), medication adherence, smoking status, blood glucose, lipid profile, body composition, and health-related quality of life. The study will also assess the mediation of behavior change by SBP PRS dissemination and genomic counseling through each Health Belief Model (HBM) construct.
Deliverables
- Change in 24-hour mean SBP at 1 year between study arms
- Change in diet (Healthy Eating Index) at 1 year
- Change in physical activity (actigraphy) at 1 year
- Change in medication adherence at 1 year
- Change in smoking status at 1 year
- Change in blood glucose at 1 year
- Change in lipid profile at 1 year
- Change in body composition (lean mass and fat mass) at 1 year
- Change in health-related quality of life at 1 year
- Assessment of mediation of behavior change by SBP PRS dissemination and genomic counseling through HBM constructs
Technical requirements
- Genome-wide systolic BP (SBP) polygenic risk score (PRS) construction and dissemination
- Genomic counseling
- 24-hour mean SBP measurement
- Healthy Eating Index assessment for diet
- Actigraphy for physical activity estimation
- Blood glucose and lipid profile measurement
- Body composition (lean mass and fat mass) assessment
