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

NCT ID: NCT04166097

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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."

Group Type EXPERIMENTAL

Heart Smart Interventional Program

Intervention Type OTHER

6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.

Interventions

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Heart Smart Interventional Program

6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacey E Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health; Katz Women's Hospital at Long Island Jewish Medical Center

Locations

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Sandra Atlas Bass Heart Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23540328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22708000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25952354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28860232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21130804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18655720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30894319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37492930 (View on PubMed)

Other Identifiers

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18-0971

Identifier Type: -

Identifier Source: org_study_id

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