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

Cardiovascular Risk Factor Clinical Trial

— Heart Smart  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166097
• Other study ID #: 18-0971
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

Other:
• Heart Smart Interventional Program
6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.

Locations

Country	Name	City	State
United States	Sandra Atlas Bass Heart Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Erratum In: J Am Coll Cardiol. 2019 Sep 10;74(10):1428-1429. J Am Coll Cardiol. 2020 Feb 25;75(7):840. — View 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. — View Citation

Kim DA, Hwong AR, Stafford D, Hughes DA, O'Malley AJ, Fowler JH, Christakis NA. Social network targeting to maximise population behaviour change: a cluster randomised controlled trial. Lancet. 2015 Jul 11;386(9989):145-53. doi: 10.1016/S0140-6736(15)60095-2. Epub 2015 May 4. — View 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. — View Citation

Riegel B, Moser DK, Buck HG, Dickson VV, Dunbar SB, Lee CS, Lennie TA, Lindenfeld J, Mitchell JE, Treat-Jacobson DJ, Webber DE; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Quality of Care and Outcomes Research. Self-Care for the Prevention and Management of Cardiovascular Disease and Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association. J Am Heart Assoc. 2017 Aug 31;6(9):e006997. doi: 10.1161/JAHA.117.006997. — View Citation

Rosen, SE, Makaryus AN, Kang L, Shaw LJ, Gajer R, Lennon W, Mieres JH. Awareness and prevalence of unidentified cardiovascular risk factors among female health system employees. Manuscript in preparation.

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. — View Citation

Thorndike AN. Workplace Interventions to Reduce Obesity and Cardiometabolic Risk. Curr Cardiovasc Risk Rep. 2011 Feb;5(1):79-85. doi: 10.1007/s12170-010-0138-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased Blood Pressure	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
Primary	Decreased Total Cholesterol	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
Primary	Decreased Low Density Lipoprotein Cholesterol (LDL-C)	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
Primary	Decreased Body Mass Index (BMI)	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
Primary	Decreased Waist Circumference	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	Decreased HbA1c		1 year
Secondary	Decreased Psychosocial Stress	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
Secondary	Decreased Depression Score	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
Secondary	Decreased Sleep Disturbance	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