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Cardiovascular Disease Risk Factors Prevalence Among Bayer's Employees in São Paulo, Brazil

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ClinicalTrials.gov Identifier: NCT02055651
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment
Occupational Health Behavioral: Examination and survey

Study Type : Observational
Actual Enrollment : 361 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
Study Start Date : August 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : October 2016

Group/Cohort Intervention/treatment
Bayer Sao Paulo employees
Workers from Bayer in site Socorro who participate in the trial
Behavioral: Examination and survey
Routine medical examination as required by law and follow-up for lifestyle change program




Primary Outcome Measures :
  1. Cardiovascular health metrics on a three-point scale (poor, intermediate, ideal) [ Time Frame: 1 day ]
    Metrics are defined by the American Heart Association (AHA) [Lloyd-Jones and cols, 2010]


Secondary Outcome Measures :
  1. Number of participants who are suggested to participate in a lifestyle change program and show up for at least one session [ Time Frame: Up to 4 weeks after cardiovascular examination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bayer's employees (São Paulo, Brazil)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055651


Locations
Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02055651     History of Changes
Other Study ID Numbers: 17312
NN1325BR ( Other Identifier: Company internal )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016

Keywords provided by Bayer:
Worksite
Cardiovascular
Epidemiology
Risk factors