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OpenTrials
Completed

NCT Number: NCT02055651

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

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Examination and survey

Behavioral

Routine medical examination as required by law and follow-up for lifestyle change program

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Feb 5, 2014
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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