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Physical Activity for Campus Employees (PACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01617499
First received: June 6, 2012
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Activity for Campus Employees

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Daily Step Count (determined by pedometer) [ Time Frame: Baseline, week 4, and week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body weight [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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.

  • Body Mass Index (BMI) [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    BMI will be computed as weight in kilograms divided by height in meters squared. Weight Status will be determined using standard CDC BMI categories.

  • Body Composition [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Fat mass (kg), fat free mass (kg), and percentage body fat will be determined by bioelectrical impedance analysis using the InBody 520 analyzer.

  • waist circumference [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Waist circumference will be measured at the border of the iliac crest using a Gulick II tape measure.

  • Blood Pressure [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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.

  • Fasting plasma glucose [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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).

  • Total Cholesterol [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Total cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).

  • LDL Cholesterol [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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).

  • HDL Cholesterol [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    HDL cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).

  • Triglycerides [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Triglycerides will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).

  • Non-HDL Cholesterol [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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).

  • Resting heart rate [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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).

  • Cardiorespiratory fitness based on post-exercise recovery heart rate [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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.

  • Dietary patterns [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Dietary patterns will be assessed using the nutrition questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).

  • Physical activity patterns [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Physical activity patterns will be assessed using the exercise questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).

  • Perceived barriers to exercise participation [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Perceived barriers to exercise participation will be assessed using the "Exercise Barriers" questionnaire, which the subject will complete on his/her own.

  • Perceived benefits of exercise [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Perceived benefits of exercise will be assessed using the "Exercise Benefits" questionnaire, which the subject will complete on his/her own.

  • Participant evaluation of the wellness program [ Time Frame: Weeks 12 - 14 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • employee of Washington University in St. Louis

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617499

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Susan B Racette, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01617499     History of Changes
Other Study ID Numbers: 201109022
Study First Received: June 6, 2012
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
physical activity
pedometer
worksite
wellness
cardiovascular
lifestyle program

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014