NCT00763308

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1 cardiovascular-diseases

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 30, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

September 25, 2008

Last Update Submit

September 26, 2008

Conditions

Keywords

WeightBlood PressureSmoking StatusCardiovascular Risk Profile

Outcome Measures

Primary Outcomes (1)

  • Change in health attitudes and behaviors

    Measured pre- and post-intervention

Secondary Outcomes (1)

  • Change in cardiovascular risk status

    Measured pre- and post-intervention

Study Arms (2)

1

EXPERIMENTAL

Participants will use the Web-based Heart Healthy program.

Behavioral: Web-based Heart Healthy Program

2

NO INTERVENTION

Participants will receive treatment as usual.

Interventions

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.

1

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No known cardiovascular risks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISA Associates, Inc.

Alexandria, Virginia, 22314, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesBody Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diane K. Deitz, PhD

    ISA Associates

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane K. Deitz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 30, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 30, 2008

Record last verified: 2008-09

Locations