Cardiovascular Disease Risk Factors Prevalence Among Bayer's Employees in São Paulo, Brazil
Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
2 other identifiers
observational
361
1 country
1
Brief Summary
Introduction: As employees spent most part of their time at the worksite, it provides a venue to address multiple individual risk factors and promote health. The America Heart Association (AHA) defined cardiovascular health using as metrics smoking status, body mass index, physical activity, diet, total cholesterol, blood pressure and fasting blood glucose. Objective: Evaluate Bayer employees' cardiovascular health according to the AHA definition and the acceptance to engage in lifestyle change programs. Methods: By the time of the annual occupational safety periodic medical examination, employees will receive an email with information about the cardiovascular health screening, exams requisition (fasting blood glucose and total cholesterol) and a copy of the written informed consent. If the employee accepts to participate, after providing a written informed consent, he will be evaluated according to the AHA cardiovascular health metrics. Data will be collected at the occupational safety electronic health record. After medical evaluation, employees will receive a printed feedback with their cardiovascular health score and will be referred to indicated lifestyle change programs (healthy weight, smoking cessation, diabetes control, high blood pressure control, dyslipidemia control). After 12 months we will evaluate the percentage of employees who accept to participate; prevalence of the cardiovascular risk factors and distribution according to the AHA classification in ideal, intermediate and poor; adherence to lifestyle change programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 11, 2016
November 1, 2016
1.3 years
January 24, 2014
November 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular health metrics on a three-point scale (poor, intermediate, ideal)
Metrics are defined by the American Heart Association (AHA) \[Lloyd-Jones and cols, 2010\]
1 day
Secondary Outcomes (1)
Number of participants who are suggested to participate in a lifestyle change program and show up for at least one session
Up to 4 weeks after cardiovascular examination
Study Arms (1)
Bayer Sao Paulo employees
Workers from Bayer in site Socorro who participate in the trial
Interventions
Routine medical examination as required by law and follow-up for lifestyle change program
Eligibility Criteria
Bayer's employees (São Paulo, Brazil)
You may qualify if:
- Employees with 20 years of age or more that daily work at Bayer's site in São Paulo
- Provide written informed consent
You may not qualify if:
- Employees that will no longer work for Bayer in 30 days
- Employees that are retired from work during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
São Paulo, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2014
First Posted
February 5, 2014
Study Start
August 1, 2013
Primary Completion
November 1, 2014
Study Completion
October 1, 2016
Last Updated
November 11, 2016
Record last verified: 2016-11