Novel Strategies for Reducing Heart Disease Risk Disparities

NCT00143923 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-09-22

No results posted yet for this study

Summary

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify differences in cardiovascular risk, (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.

This is a prospective cohort study of 2,000 residents of the state of Pennsylvania. 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 differences in cardiovascular risk among high risk populations. All participants will undergo long-term follow-up for cardiovascular events.

Conditions

Interventions

BEHAVIORAL

Nutrition, Exercise, Stress Management Counseling

Individualized advice

OTHER

usual care

usual care

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Steven E Reis, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00143923 on ClinicalTrials.gov