NCT02055651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

January 24, 2014

Last Update Submit

November 10, 2016

Conditions

Keywords

WorksiteCardiovascularEpidemiologyRisk factors

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

Bayer Sao Paulo employees

Workers from Bayer in site Socorro who participate in the trial

Behavioral: Examination and survey

Interventions

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

Bayer Sao Paulo employees

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bayer's employees (São Paulo, Brazil)

You may qualify if:

  • Employees with 20 years of age or more that daily work at Bayer's site in São Paulo
  • Provide written informed consent

You may not qualify if:

  • Employees that will no longer work for Bayer in 30 days
  • Employees that are retired from work during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Interventions

Restraint, PhysicalSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

February 5, 2014

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

October 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations