Primary Prevention of Cardiovascular Disease Among Female Hospital Employees: The Heart Smart for Women Intervention (Heart Smart)

September 25, 2023 updated by: Northwell Health

This study aims to show that a 6-week program designed specifically for women can lead to sustainable behavior change and improvement in heart disease risk factors over one year among a cohort of 46 female employees recruited from within the Heart Hospital at North Shore University Hospital (NSUH). The program is adapted from book "Heart Smart for Women: Six S. T. E. P. S in Six Weeks to Heart-Healthy Living," written by Northwell cardiologists Dr. Jennifer H. Mieres and Dr. Stacey E. Rosen.

The 6-week intervention will include a weekly didactic session, with each week devoted to a different theme (food, exercise, etc). The intervention will follow the program outlined in the book. We will also be using Yammer, an online discussion group part of the Office 365 suite, to distribute materials and encourage conversations surrounding the theme of the week.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart Disease is the leading cause of death in women in the United State. Nine out of ten women have one or more risk factors for heart disease and one in three women will die of heart disease. However, most women are unaware of these statistics. As a result, women are less likely than men to recognize the symptoms of a heart attack and are more likely than men to delay in seeking help. The best ways to educate women about heart disease and change their behavior to prevent heart disease are unknown.

More than 80% of heart disease is preventable but requires both knowledge of risk factors and adherence to lifestyle changes. This program is designed to address these challenges in women, where this is a particular unmet need.

Some prior community and workplace-based studies have demonstrated short term improvements in modifiable risk factors for cardiovascular disease. A community based primary prevention program among disadvantaged women decreased the rate of metabolic syndrome, anxiety, depression and stress.

The economic burden of heart disease on employers is significant although workplace employee wellness programs have not been shown to decrease employer costs. The impact of employee wellness programs on clinical outcome measures have been inconsistent.

This program is designed to educate female employees about their heart disease risk factors and provide tactical support to improve their heart health. Once validated, the program can be rolled out to other employees and to the community.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Sandra Atlas Bass Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • one or more of the following modifiable risk factors for cardiovascular disease [as defined by the American Heart Association]:

    1. cigarette smoking
    2. high blood pressure
    3. high cholesterol
    4. abnormal blood sugar
    5. sedentary lifestyle
    6. overweight/obese
  • must be an employee of the Heart Hospital at North Shore University Hospital

Exclusion Criteria:

  • prior history of heart attack or stroke
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart Smart Interventional Program
Subjects participate in this 6-week intervention which include a weekly didactic session, with each week devoted to a different theme (food, exercise, etc). The intervention will follow the program outlined in the book "Heart Smart for Women: Six S. T. E. P. S. in Six Weeks to Heart-Healthy Living."
Other: Heart Smart Interventional Program
6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Blood Pressure
Time Frame: 1 year

Blood Pressure at a single follow-up measured as 2 readings separated by 5 minutes. This will be observed at baseline, end of 6-week program, 3 months post-completion, 6 months post-completion, and 1 year post-completion.

Significant change in this outcome will be defined as a difference in means of 7 mmHg between baseline average and follow-up average.
1 year
Decreased Total Cholesterol
Time Frame: 1 year
Total Cholesterol measured by lipid profile of blood drawn. This will be observed at baseline, end of 6-week program, 3 months post-completion, 6 months post-completion, and 1 year post-completion.
1 year
Decreased Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: 1 year
Low Density Lipoprotein Cholesterol (LDL-C) measured by lipid profile of blood drawn. This will be observed at baseline, end of 6-week program, 3 months post-completion, 6 months post-completion, and 1 year post-completion.
1 year
Decreased Body Mass Index (BMI)
Time Frame: 1 year
Weight in kilograms and height in meters will be combined to report BMI in kg/m^2. This will be observed at baseline, end of 6-week program, 3 months post-completion, 6 months post-completion, and 1 year post-completion.
1 year
Decreased Waist Circumference
Time Frame: 1 year
This will be observed at baseline, end of 6-week program, 3 months post-completion, 6 months post-completion, and 1 year post-completion.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased HbA1c
Time Frame: 1 year
1 year
Decreased Psychosocial Stress
Time Frame: 1 year
Psychosocial Stress scored via the Perceived Stress Scale (PSS). The minimum value is 0 and the maximum value is 40, with higher scores meaning worse outcome.
1 year
Decreased Depression Score
Time Frame: 1 year
Depression scored via Patient Health Questionnaire-4 (PHQ-4). The minimum value is 0 and the maximum value, with higher scores meaning worse outcome. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
1 year
Decreased Sleep Disturbance
Time Frame: 1 year
Sleep Disturbance scored via Pittsburgh Sleep Quality Index (PSQI). The minimum value is 0 and the maximum value is 21, with higher scores meaning worse sleep quality.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Stacey E Rosen, MD, Northwell Health; Katz Women's Hospital at Long Island Jewish Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The PI has identified an independent data and safety monitor, Dr. Penny Stern, who has expertise in cardiovascular prevention and who does not have any scientific, financial, or other conflict of interest related to the study and who is not responsible for patient care at any of the participating sites.

Study protocol will be reviewed and record keeping done every 3 months to ensure that all employee/participant information is kept confidential.

Password-protected database will be used to enter all data - it will contain only de-identified information. Moreover, the online discussion group, Yammer, activity will be reviewed to ensure participant confidentiality is maintained and that unauthorized disclosure of information outside the private group is prevented.

IPD Sharing Time Frame

Data available: January 2020 Duration available: 1 year, 1 month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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