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Physical Activity for Campus Employees (PACE)

2015年5月19日 更新者:Washington University School of Medicine
The aim of this pilot study is to evaluate the effects of a worksite wellness program on physical activity and cardiovascular disease risk factors among university employees. The investigators hypothesize that the proposed worksite wellness program will be effective for increasing daily physical activity and improving one or more cardiovascular disease risk factors among university employees.

研究概览

地位

完全的

详细说明

Cardiovascular disease (CVD) persists as the leading cause of mortality in the United States and accounts for 17 percent of the nation's overall health expenditures. Although the mortality rate of CVD has declined in recent years, the burden of disease remains high. Currently, 1 in 3 Americans has some form of CVD. Additionally, according to a recent policy statement published by the American Heart Association (AHA), 40% of the population is projected to have some form of CVD by 2030. Furthermore, the AHA has projected that the cost to treat CVD will triple by 2030. The prevalence and rising financial burden of CVD demonstrate the urgency for effective implementation of disease prevention strategies.

Evidence suggesting the majority of CVD is preventable through modifiable risk factor management continues to grow. Nonetheless, difficulty controlling modifiable risk factors remains an issue for many Americans. The magnitude of this challenge is supported by a study revealing that 78% of adults are candidates for at least one CVD prevention activity. Although national organizations have published a variety of disease prevention recommendations, widespread implementation of and adherence to preventative programs remain problematic. Consequently, a large proportion of the population is not receiving or participating in prevention strategies from which they may benefit. The full potential of reducing the nation's CVD burden cannot be achieved unless interventions are implemented on a larger scale, with reduced costs, and with increased initial and continued participation.

With approximately 130 million Americans currently employed, workplaces provide ideal environments for implementation of sizable, cost-effective CVD prevention programs. However, successful wellness programming remains a laborious, resource intensive challenge for employers. In 2004, a National Worksite Health Promotion Survey disclosed that less than 7% of U.S. employers offered worksite wellness programs. Furthermore, an estimated 25-30% of companies' annual medical costs are spent on employees with CVD risk factors.

In the proposed study, a worksite wellness program that includes health assessments, personal health reports, and pedometer-based tracking of physical activity will be offered to university employees. Participants will not be randomized to an intervention or control group. Rather, program components will be available to all enrolled participants, and each individual may choose whether to wear a pedometer, track their step counts, attend wellness sessions, and/or complete the health assessments. There is no prescribed intervention. Wellness sessions include educational information on lifestyle behaviors to promote cardiometabolic health.

研究类型

观察性的

注册 (实际的)

141

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Missouri
      • St. Louis、Missouri、美国、63108
        • Washington University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will consist of employees of Washington University in St. Louis. A convenience sample of staff employees located on the Danforth campus will be enrolled.

描述

Inclusion Criteria:

  • employee of Washington University in St. Louis

Exclusion Criteria:

  • pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
University employees
Participants will include employees of Washington University in St. Louis. Recruitment will be directed to staff employees of the Central Fiscal Unit (CFU) on the Danforth campus.
The worksite wellness program included cardiovascular health assessments, personal health reports, 8 weeks of pedometer-based walking and tracking activities, and weekly wellness sessions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Daily Step Count (determined by pedometer)
大体时间:Baseline, week 4, and week 8
Daily step counts, as recorded by pedometers, will be self-reported by participants for 7 continuous days at 3 study time points: baseline, week 4, and week 8.
Baseline, week 4, and week 8

次要结果测量

结果测量
措施说明
大体时间
Body weight
大体时间:Baseline and week 9
Body weight will be measured on a digital scale in the morning after an overnight fast. Shoes, jewelry, sweaters, jackets, belts, and hats will be removed and pockets will be emptied before the measurement is made.
Baseline and week 9
Body Mass Index (BMI)
大体时间:Baseline and week 9
BMI will be computed as weight in kilograms divided by height in meters squared. Weight Status will be determined using standard CDC BMI categories.
Baseline and week 9
Body Composition
大体时间:Baseline and week 9
Fat mass (kg), fat free mass (kg), and percentage body fat will be determined by bioelectrical impedance analysis using the InBody 520 analyzer.
Baseline and week 9
waist circumference
大体时间:Baseline and week 9
Waist circumference will be measured at the border of the iliac crest using a Gulick II tape measure.
Baseline and week 9
Blood Pressure
大体时间:Baseline and week 9
Systolic and diastolic blood pressure will be measured in duplicate in the right arm after 10 minutes of seated rest using the Omron HEM-907XL Professional Digital Blood Pressure Monitors (Omron Healthcare, Kyoto, Japan). One minute rest will be provided between the 2 measurements.
Baseline and week 9
Fasting plasma glucose
大体时间:Baseline and week 9
Fasting plasma glucose will be measured from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
Total Cholesterol
大体时间:Baseline and week 9
Total cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
LDL Cholesterol
大体时间:Baseline and week 9
LDL cholesterol will be computed using the Friedewald equation from the lipid profile measured from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
HDL Cholesterol
大体时间:Baseline and week 9
HDL cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
Triglycerides
大体时间:Baseline and week 9
Triglycerides will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
Non-HDL Cholesterol
大体时间:Baseline and week 9
Non-HDL cholesterol will be computed by difference based on the lipid profile determined from a fasted fingerstick blood sample using the Cholestech LDX System® (Hayward, CA).
Baseline and week 9
Resting heart rate
大体时间:Baseline and week 9
Resting heart rate will be measured in duplicate in the morning after 10 minutes of seated rest using Omron HEM-907XL Professional Digital Blood Pressure Monitors (Omron Healthcare, Kyoto, Japan).
Baseline and week 9
Cardiorespiratory fitness based on post-exercise recovery heart rate
大体时间:Baseline and week 9
Cardiorespiratory fitness will be estimated based on heart rate recovery following a 3-minute step test performed with an 8-inch step and a metronome set to 96 beats/minute. Participants will be instructed to maintain the pace set by the beat of the metronome for 3 consecutive minutes and to be seated immediately at the completion of the 3-minute test. The subject's right radial pulse rate will be measured for 30 seconds, beginning 30 seconds after the completion of the test. Cardiorespiratory fitness level will be computed based on sex- and age-specific heart rate criteria.
Baseline and week 9
Dietary patterns
大体时间:Baseline and week 9
Dietary patterns will be assessed using the nutrition questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
Baseline and week 9
Physical activity patterns
大体时间:Baseline and week 9
Physical activity patterns will be assessed using the exercise questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
Baseline and week 9
Perceived barriers to exercise participation
大体时间:Baseline and week 9
Perceived barriers to exercise participation will be assessed using the "Exercise Barriers" questionnaire, which the subject will complete on his/her own.
Baseline and week 9
Perceived benefits of exercise
大体时间:Baseline and week 9
Perceived benefits of exercise will be assessed using the "Exercise Benefits" questionnaire, which the subject will complete on his/her own.
Baseline and week 9
Participant evaluation of the wellness program
大体时间:Weeks 12 - 14
Participants will be asked to provide feedback about the wellness program through a 10-question, anonymous, online survey administered using the web-based Survey Monkey tool.
Weeks 12 - 14

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Susan B Racette, PhD、Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2012年6月6日

首先提交符合 QC 标准的

2012年6月11日

首次发布 (估计)

2012年6月12日

研究记录更新

最后更新发布 (估计)

2015年5月21日

上次提交的符合 QC 标准的更新

2015年5月19日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 201109022

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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