check_circleStudy Completed

Occupational Health

Bayer Identifier:

17312

ClinicalTrials.gov Identifier:

NCT02055651

EudraCT Number:

Not Available

EU CT Number:

Not Available
Cardiovascular disease risk factors prevalence among Bayer's employees in São Paulo, Brazil

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Employees with 20 years of age or more that daily work at Bayer’s site in São Paulo
    - Provide written informed consent
  • - Employees that will no longer work for Bayer in 30 days
    - Employees that are retired from work during the study period

Trial summary

Enrollment Goal
361
Trial Dates
August 2013 - October 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Sao Paulo, Brazil

Primary Outcome

  • 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]
    date_rangeTime Frame:
    1 day
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    Safety Issue:
    No

Secondary Outcome

  • Number of participants who are suggested to participate in a lifestyle change program and show up for at least one session
    date_rangeTime Frame:
    Up to 4 weeks after cardiovascular examination
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    Safety Issue:
    No

Trial design

Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
Trial Type
Observational
Intervention Type
Behavioral
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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