Lifestyle Interventions for Heart Disease Risk Reduction (HeartSCORE Trial)

Recruiting in Palo Alto (17 mi)

Overseen BySteven E Reis, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pittsburgh

Trial Summary

What is the purpose of this trial?This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify disparities in cardiovascular risk based on race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations. These goals, which are designed to eliminate ethnic and racial health disparities, are closely tied to the National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's health promotion and disease prevention agenda established in Healthy People 2010. This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with approximately equal representation of white and African American subjects. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate racial, socioeconomic and geographic disparities in cardiovascular risk. All participants will undergo long-term follow-up for cardiovascular events.

Eligibility Criteria

This trial is for Pennsylvania residents aged 45-75 who may be at risk of heart disease. It's not suitable for those with a life expectancy under 5 years, unable to attend regular visits, or pregnant women (excluded from X-ray studies).

Inclusion Criteria

I am between 45 and 75 years old.

Exclusion Criteria

I have a health condition that may shorten my life to under 5 years.

Participant Groups

The study tests if better risk identification and community programs like nutrition advice, exercise routines, and stress management can reduce heart disease risks in high-risk groups. Participants will either receive usual care or join the intervention program.

3Treatment groups

Active Control

Placebo Group

Group I: 1Active Control1 Intervention

Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1

Group II: 3Active Control1 Intervention

No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling

Group III: 2Placebo Group1 Intervention

Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling