Clinical trial NCT01617499: Physical Activity for Campus Employees
Official title: Physical Activity for Campus Employees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: physical activity
pedometer
worksite
wellness
cardiovascular
lifestyle program
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* employee of Washington University in St. Louis

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Daily Step Count (determined by pedometer)
timeFrame: Baseline, week 4, and week 8
Secondary outcomes:
measure: Body weight
timeFrame: Baseline and week 9
measure: Body Mass Index (BMI)
timeFrame: Baseline and week 9
measure: Body Composition
timeFrame: Baseline and week 9
measure: waist circumference
timeFrame: Baseline and week 9
measure: Blood Pressure
timeFrame: Baseline and week 9
measure: Fasting plasma glucose
timeFrame: Baseline and week 9
measure: Total Cholesterol
timeFrame: Baseline and week 9
measure: LDL Cholesterol
timeFrame: Baseline and week 9
measure: HDL Cholesterol
timeFrame: Baseline and week 9
measure: Triglycerides
timeFrame: Baseline and week 9
measure: Non-HDL Cholesterol
timeFrame: Baseline and week 9
measure: Resting heart rate
timeFrame: Baseline and week 9
measure: Cardiorespiratory fitness based on post-exercise recovery heart rate
timeFrame: Baseline and week 9
measure: Dietary patterns
timeFrame: Baseline and week 9
measure: Physical activity patterns
timeFrame: Baseline and week 9
measure: Perceived barriers to exercise participation
timeFrame: Baseline and week 9
measure: Perceived benefits of exercise
timeFrame: Baseline and week 9
measure: Participant evaluation of the wellness program
timeFrame: Weeks 12 - 14
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Susan B Racette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butler CE, Clark BR, Burlis TL, Castillo JC, Racette SB. Physical Activity for Campus Employees: A University Worksite Wellness Program. J Phys Act Health. 2015 Apr;12(4):470-6. doi: 10.1123/jpah.2013-0185. Epub 2014 Jun 4.