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Clinical Trials/NCT04166097
NCT04166097
Active, not recruiting
Not Applicable

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

Northwell Health1 site in 1 country46 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Risk Factor
Sponsor
Northwell Health
Enrollment
46
Locations
1
Primary Endpoint
Decreased Blood Pressure
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
December 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • one or more of the following modifiable risk factors for cardiovascular disease \[as defined by the American Heart Association\]:
  • cigarette smoking
  • high blood pressure
  • high cholesterol
  • abnormal blood sugar
  • sedentary lifestyle
  • 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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Decreased Depression Score(1 year)
  • Decreased HbA1c(1 year)
  • Decreased Psychosocial Stress(1 year)
  • Decreased Sleep Disturbance(1 year)

Study Sites (1)

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