In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.
This parallel-arm, randomized clinical trial is designed to assess the change in SBP following BP PRS dissemination and genomic counseling. Investigators will enroll 300 young and middle-aged adults (age: 18-55 years; 50% females; 50% non-White) with HTN \[stratified by race, sex, and SBP PRS group (high vs. low/intermediate)\] and poor CVH \[American Heart Association's (AHA) Life Essential 8 Score: 0-50\]. Participants will be randomized to A) routine clinical care (N=150), or B) SBP PRS dissemination (regular care + SBP PRS delivery and genetic counseling; N=150). After obtaining informed consent, the eligible participants will undergo genotyping and computation of their genome-wide SBP PRS. The SBP PRS results will be available within 10-15 days of screening. Participants will then be randomized in a 1:1 manner \[stratified by sex, racial/ethnic group (White vs. non-White), and SBP PRS (high vs. low/intermediate)\] to either the SBP PRS dissemination arm or the routine care arm. Participants will undergo a comprehensive baseline health assessment, including measurement of key HBM constructs, using the recently developed Attitudes and Beliefs about the CVD (ABCD) Risk Questionnaire, a 26-item instrument validated in the clinical setting with four subscales: perceived risk of heart attack/stroke, perceived benefits and intentions to exercise, healthy eating intentions, and perceived benefits and intentions to reducing smoking. Investigators will also assess the perceived severity of CVD, perceived barriers to prevention behaviors, and self-efficacy to perform preventive behaviors using subscales previously assessed for content and face validity by an expert review panel and patient focus groups. Physical activity status and sleep duration (using 7-day Actigraphy), detailed dietary history \[using the United States Department of Agriculture (USDA) Healthy Eating Index and collected through the validated Nutrition Coordinating Center Nutrition Data System for Research (NCC NDSR) dietary assessment tool\], health-related quality of life \[using 36-Item Short Form Survey (SF-36), and the Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life-14 (HRQOL-14)\], medication adherence using the Medication Adherence Rating Scale (MARS), 24-hour ambulatory blood pressure monitoring (ABPM), current health behaviors (smoking, alcohol, recreational drugs), and other cardiometabolic health parameters \[lipid profile, hemoglobin A1c (HbA1c), body mass index (BMI), and body composition), and anxiety \[using the Beck Anxiety Inventory (BAI)\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
Educational brochures and lifestyle guidance on blood pressure control, medication adherence, physical activity, and healthy diet, provided at baseline only. No additional counseling or genetic risk disclosure will occur during the 12-month intervention period.
Participants receive individualized SBP PRS reports and structured genomic counseling sessions delivered by trained genetic counselors. Counseling addresses key constructs of the Health Belief Model, including perceived susceptibility, severity, and benefits of behavior change, with an emphasis on lifestyle modification and medication adherence.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGChange in Mean 24-Hour Systolic Blood Pressure
The difference in the 24-hour mean systolic BP between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Physical Activity Levels
Physical activity levels in MET·hr-1·wk-1 estimated using 7-day actigraphy. The difference in the physical activity levels (MET·hr-1·wk-1) between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Healthy Diet Index Score
The USDA Healthy Eating Index (HEI-2015) will be used to estimate changes in diet quality. The HEI score ranges from 0 to 100, with higher scores indicating better adherence to the Dietary Guidelines for Americans (i.e., better diet quality). The outcome measure will be the difference in HEI scores between the two study groups at 1 year, adjusted for baseline
Time frame: 1 year
Change in Medication Adherence
Medication adherence will be assessed using the Medication Adherence Report Scale (MARS-5). The MARS-5 scale has a score range from 5 to 25, with higher scores indicating better adherence. The outcome measure will be the difference in MARS-5 scores between the two study groups at 1 year, adjusted for baseline
Time frame: 1 year
Change in Ambulatory Blood Pressure Parameters
The difference in the 24-hour mean diastolic BP, daytime systolic BP, daytime diastolic BP, nighttime systolic BP, and nighttime diastolic BP between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Lipid Profile
The difference in the low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, and total cholesterol levels between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Sleep Duration
The difference in the sleep duration estimated using 7-day actigraphy, between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Body Mass Index
The difference in the body mass index between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Fat Mass
The difference in the fat mass between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Lean Mass
The difference in the lean mass between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Health Belief Model Constructs
The difference in the Health Belief Model constructs, measured using standardized questionnaires, between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Smoking Behavior
Estimated as the number of cigarettes per week. The difference in the number of cigarettes per week between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
Change in Health-Related Quality of Life (SF-36)
Assessed using the 36-Item Short Form Survey (SF-36). The SF-36 produces scores ranging from 0 to 100, with higher scores indicating better quality of life. The difference between study groups at 1 year will be assessed, adjusted for baseline.
Time frame: 1 year
Change in Health-Related Quality of Life (CDC HRQOL-14)
Assessed using the Centers for Disease Control and Prevention Health-Related Quality of Life 14-item measure (CDC HRQOL-14). The number of physically and mentally unhealthy days is recorded, with higher numbers indicating worse quality of life. The difference between study groups at 1 year will be assessed, adjusted for baseline.
Time frame: 1 year
Change in Anxiety
Anxiety will be assessed using the Beck Anxiety Inventory (BAI). The BAI scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms. The outcome measure will be the difference in BAI scores between the two study groups at 1 year, adjusted for baseline.
Time frame: 1 year
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