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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02055651
First received: January 24, 2014
Last updated: June 27, 2014
Last verified: June 2014
  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.


Condition Intervention
Occupational Health
Behavioral: Examination and survey

Study Type: Observational
Study Design: 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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cardiovascular health metrics on a three-point scale (poor, intermediate, ideal) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Metrics are defined by the American Heart Association (AHA) [Lloyd-Jones and cols, 2010]


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055651

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02055651     History of Changes
Other Study ID Numbers: 17312, NN1325BR
Study First Received: January 24, 2014
Last Updated: June 27, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Bayer:
Worksite
Cardiovascular
Epidemiology
Risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014