Clinical trial NCT04166097: Primary Prevention of Cardiovascular Disease Among Female Hospital Employees: The Heart Smart for Women Intervention
Official title: Primary Prevention of Cardiovascular Disease Among Female Hospital Employees: The Heart Smart for Women Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreased Blood Pressure
timeFrame: 1 year
measure: Decreased Total Cholesterol
timeFrame: 1 year
measure: Decreased Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 1 year
measure: Decreased Body Mass Index (BMI)
timeFrame: 1 year
measure: Decreased Waist Circumference
timeFrame: 1 year
Secondary outcomes:
measure: Decreased HbA1c
timeFrame: 1 year
measure: Decreased Psychosocial Stress
timeFrame: 1 year
measure: Decreased Depression Score
timeFrame: 1 year
measure: Decreased Sleep Disturbance
timeFrame: 1 year
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Sandra Atlas Bass Heart Hospital
state: New York
Study officials:
affiliation: Northwell Health; Katz Women's Hospital at Long Island Jewish Medical Center
name: Stacey E Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilstrap LG, Malhotra R, Peltier-Saxe D, Slicas D, Pineda E, Culhane-Hermann C, Cook N, Fernandez-Golarz C, Wood M. Community-based primary prevention programs decrease the rate of metabolic syndrome among socioeconomically disadvantaged women. J Womens Health (Larchmt). 2013 Apr;22(4):322-9. doi: 10.1089/jwh.2012.3854. Epub 2013 Mar 29.
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citation: Thorndike AN, Healey E, Sonnenberg L, Regan S. Participation and cardiovascular risk reduction in a voluntary worksite nutrition and physical activity program. Prev Med. 2011 Feb;52(2):164-6. doi: 10.1016/j.ypmed.2010.11.023. Epub 2010 Dec 3.
citation: Richardson G, van Woerden HC, Morgan L, Edwards R, Harries M, Hancock E, Sroczynsk S, Bowley M. Healthy hearts--a community-based primary prevention programme to reduce coronary heart disease. BMC Cardiovasc Disord. 2008 Jul 26;8:18. doi: 10.1186/1471-2261-8-18.
citation: Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Sep 10;74(10):1376-1414. doi: 10.1016/j.jacc.2019.03.009. Epub 2019 Mar 17.
citation: Makaryus AN, Rosen SE, Kang L, Shaw LJ, Nash B, Gajer R, Coppolino W, Mieres JH. Racial and Ethnic Differences in Awareness and Prevalence of Unidentified Cardiovascular Risk Factors Among Health System Employees. Am J Health Promot. 2023 Nov;37(8):1091-1099. doi: 10.1177/08901171231192484. Epub 2023 Jul 26.