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

Occupational Health Clinical Trial

Official title:

Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055651
• Other study ID #: 17312
• Secondary ID: NN1325BR
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: November 10, 2016
• Start date: August 2013
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Occupational Health

Intervention

Behavioral:
• Examination and survey
Routine medical examination as required by law and follow-up for lifestyle change program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

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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