Occupational Health Clinical Trial
Official title:
Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
Verified date | November 2016 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 361 |
Est. completion date | October 2016 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Employees with 20 years of age or more that daily work at Bayer's site in São Paulo - Provide written informed consent Exclusion Criteria: - Employees that will no longer work for Bayer in 30 days - Employees that are retired from work during the study period |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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