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

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Risk Factor
• Interventions: Other: Heart Smart Interventional Program

• Registration Number: NCT04166097
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-01-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Smart Interventional Program	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."

Primary Outcome Measures

Name	Time	Method
Decreased Blood Pressure	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)	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	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	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)	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 Outcome Measures

Name	Time	Method
Decreased Depression Score	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).
Decreased HbA1c	1 year
Decreased Psychosocial Stress	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.
Decreased Sleep Disturbance	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.

Trial Locations

Locations (1)

Sandra Atlas Bass Heart Hospital; 🇺🇸 Manhasset, New York, United States