Cardiovascular DiseasePACENCT01617499
Physical Activity for Campus Employees
An observational study of Cardiovascular Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- employee of Washington University in St. Louis
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Physical activity
- Keywords
- physical activity, pedometer, worksite, wellness, cardiovascular, lifestyle program
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
The worksite wellness program included cardiovascular health assessments, personal health reports, 8 weeks of pedometer-based walking and tracking activities, and weekly wellness sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Step Count (determined by pedometer)
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.
Measured: Baseline, week 4, and week 8
Secondary outcomes (18)
Body weight
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.
Measured: Baseline and week 9
Body Mass Index (BMI)
BMI will be computed as weight in kilograms divided by height in meters squared. Weight Status will be determined using standard CDC BMI categories.
Measured: Baseline and week 9
Body Composition
Fat mass (kg), fat free mass (kg), and percentage body fat will be determined by bioelectrical impedance analysis using the InBody 520 analyzer.
Measured: Baseline and week 9
waist circumference
Waist circumference will be measured at the border of the iliac crest using a Gulick II tape measure.
Measured: Baseline and week 9
Blood Pressure
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.
Measured: Baseline and week 9
Fasting plasma glucose
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).
Measured: Baseline and week 9
Total Cholesterol
Total cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Measured: Baseline and week 9
LDL Cholesterol
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).
Measured: Baseline and week 9
HDL Cholesterol
HDL cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Measured: Baseline and week 9
Triglycerides
Triglycerides will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
Measured: Baseline and week 9
Non-HDL Cholesterol
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).
Measured: Baseline and week 9
Resting heart rate
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).
Measured: Baseline and week 9
Cardiorespiratory fitness based on post-exercise recovery heart rate
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.
Measured: Baseline and week 9
Dietary patterns
Dietary patterns will be assessed using the nutrition questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
Measured: Baseline and week 9
Physical activity patterns
Physical activity patterns will be assessed using the exercise questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
Measured: Baseline and week 9
Perceived barriers to exercise participation
Perceived barriers to exercise participation will be assessed using the "Exercise Barriers" questionnaire, which the subject will complete on his/her own.
Measured: Baseline and week 9
Perceived benefits of exercise
Perceived benefits of exercise will be assessed using the "Exercise Benefits" questionnaire, which the subject will complete on his/her own.
Measured: Baseline and week 9
Participant evaluation of the wellness program
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.
Measured: Weeks 12 - 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan B Racette, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617499
- Sponsor's protocol ID
- 201109022
- Acronym
- PACE
- Status last verified
- May 2015
- First submitted
- 6 Jun 2012
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24905703
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for Campus Employees
- ClinicalTrials.gov ID
- NCT01617499
- Acronym / sponsor ID
- PACE / 201109022
- Conditions
- Cardiovascular Disease
- Keywords
- physical activity, pedometer, worksite, wellness, cardiovascular, lifestyle program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University employees | – | Behavioral: Physical activityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- employee of Washington University in St. Louis
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe worksite wellness program included cardiovascular health assessments, personal health reports, 8 weeks of pedometer-based walking and tracking activities, and weekly wellness sessions. | Behavioural | University employees |
Primary outcome
Daily Step Count (determined by pedometer)
Time frame: 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.
18 secondary outcomes
Body weight
Time frame: Baseline and week 9
Body Mass Index (BMI)
Time frame: Baseline and week 9
Body Composition
Time frame: Baseline and week 9
waist circumference
Time frame: Baseline and week 9
Blood Pressure
Time frame: Baseline and week 9
Fasting plasma glucose
Time frame: Baseline and week 9
Total Cholesterol
Time frame: Baseline and week 9
LDL Cholesterol
Time frame: Baseline and week 9
HDL Cholesterol
Time frame: Baseline and week 9
Triglycerides
Time frame: Baseline and week 9
Non-HDL Cholesterol
Time frame: Baseline and week 9
Resting heart rate
Time frame: Baseline and week 9
Cardiorespiratory fitness based on post-exercise recovery heart rate
Time frame: Baseline and week 9
Dietary patterns
Time frame: Baseline and week 9
Physical activity patterns
Time frame: Baseline and week 9
Perceived barriers to exercise participation
Time frame: Baseline and week 9
Perceived benefits of exercise
Time frame: Baseline and week 9
Participant evaluation of the wellness program
Time frame: Weeks 12 - 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Results publication: PubMed 24905703Butler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan B Racette, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Step Count (determined by pedometer) (time frame: Baseline, week 4, and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.