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A Web-Based Cardiovascular Intervention for the Workplace

Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763308
Enrollment
300
Registered
2008-09-30
Start date
2009-04-30
Completion date
2010-02-28
Last updated
2008-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Weight, Blood Pressure, Smoking Status, Cardiovascular Risk Profile

Brief summary

Heart disease is the leading cause of death in the United States, accounting for approximately 700,000 deaths a year. Heart disease can take many forms, including heart attacks, coronary artery disease, aneurysms, high blood pressure, and strokes. However, people can change things in their life to reduce the risk of getting heart disease. This study will first create an Internet-based program to help teach people about reducing heart disease risk and will then test the program in a workplace setting.

Detailed description

Heart disease, or cardiovascular disease, refers to a range of diseases including coronary artery disease, heart attack, heart failure, high blood pressure, and stroke. These diseases are all related to problems with the heart and blood vessels, and collectively are the leading cause of death in the United States. Heart attacks or coronary artery disease sometimes have warning signs, but both can occur without warning. Approximately half of all heart attacks are fatal. Forty percent of all deaths in the United States are the result of heart disease. Certain factors can predict whether people get heart disease. Some of these factors, like biological sex or genes inherited from a person's family, cannot be changed, but many others can. Not smoking, eating well, exercising regularly, and maintaining a healthy weight are some of the things people can do to lower their risk of heart disease. This study will develop and then test an Internet-based program that teaches people about heart health and supports them in changing behaviors that put them at risk for heart disease. This study will be divided into two phases. In the first phase, researchers will create the Heart Healthy program, show it to focus groups, and try to improve it based on their comments. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease. The program will be designed for employee use in a workplace, and a tool kit will be developed for managers to supplement the employee program. The prototype will include modified segments from existing Web-based programs created by a non-profit organization, the ISA Group. The design of the program will be guided by feedback from employees and managers who use it and from experts in cardiology and epidemiology. In the second phase, the program will be tested in a work site. Employees at risk for heart disease will be recruited and randomly assigned to receive either the Healthy Heart program or treatment as usual. Before and after the intervention, participants will be assessed on knowledge gained, attitudes changed, alterations in health behavior, and reductions in cardiovascular risk. Managers who receive the supplementary program will be tested in knowledge gained and plans for policy or procedural changes. The ultimate goal of this phase is to fully develop the Healthy Heart program for use in industry and health care settings.

Interventions

BEHAVIORALWeb-based Heart Healthy Program

The Heart Healthy program will be developed during the course of the study based on goals set by researchers and based on feedback from focus groups. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease.

Sponsors

National Institute for Occupational Safety and Health (NIOSH/CDC)
CollaboratorFED
National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Works in participating company * At least one cardiovascular risk factor

Exclusion criteria

* No known cardiovascular risks

Design outcomes

Primary

MeasureTime frame
Change in health attitudes and behaviorsMeasured pre- and post-intervention

Secondary

MeasureTime frame
Change in cardiovascular risk statusMeasured pre- and post-intervention

Countries

United States

Contacts

Primary ContactDiane K. Deitz, PhD
ddeitz@isagroup.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026