NCT00143923

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
43mo left

Started Mar 2003

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2003Dec 2029

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
24.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

26.8 years

First QC Date

September 1, 2005

Last Update Submit

September 17, 2025

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular DiseasesRisk FactorsSleep disordered breathingEnvironmental exposuresCognitive Function

Outcome Measures

Primary Outcomes (1)

  • CVD Events

    Major adverse cardiovascular events

    20 years

Study Arms (3)

1

ACTIVE COMPARATOR

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

Behavioral: Nutrition, Exercise, Stress Management Counseling

2

PLACEBO COMPARATOR

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

Other: usual care

3

NO 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

Interventions

Nutrition, Exercise, Stress Management CounselingBEHAVIORAL

Individualized advice

1
usual careOTHER

usual care

2

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women age 45-75 years

You may not qualify if:

  • Comorbidity that is expected to limit life expectancy to \<5 years
  • Inability to undergo baseline or annual follow-up visits
  • Pregnancy (exclude women from Xray studies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesSleep Apnea Syndromes

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven E Reis, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

March 1, 2003

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)