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临床试验/NCT04166097
NCT04166097进行中(未招募)不适用

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

Northwell Health2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
46
试验地点
2
主要终点
Decreased Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • one or more of the following modifiable risk factors for cardiovascular disease [as defined by the American Heart Association]:
  • cigarette smoking
  • high blood pressure
  • high cholesterol
  • abnormal blood sugar
  • sedentary lifestyle
  • overweight/obese
  • must be an employee of the Heart Hospital at North Shore University Hospital

排除标准

  • prior history of heart attack or stroke
  • pregnancy

结局指标

主要结局

Decreased Blood Pressure

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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.

次要结局

  • Decreased Depression Score(1 year)
  • Decreased HbA1c(1 year)
  • Decreased Psychosocial Stress(1 year)
  • Decreased Sleep Disturbance(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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