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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
46 participants
INTERVENTIONAL
2020-01-15
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhancing Support for Women at Risk for Heart Disease
NCT00142701
StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women
NCT01439477
Preventative Screening and Health Coaching in a Food Insecure Population
NCT06907524
Evaluation of Low Literacy CVD Nutrition Education
NCT00005726
Preventive Health Practices in Women
NCT00724399
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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."
Heart Smart Interventional Program
6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Heart Smart Interventional Program
6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* pregnancy
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwell Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stacey E Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health; Katz Women's Hospital at Long Island Jewish Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sandra Atlas Bass Heart Hospital
Manhasset, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-0971
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.