Occupational HealthNCT02055651
Cardiovascular Disease Risk Factors Prevalence Among Bayer's Employees in São Paulo, Brazil
An observational study of Occupational Health, run by Bayer at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Health
- What is being tested?
- Examination and survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 361 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bayer's employees (São Paulo, Brazil)
Who may be able to join
- Employees with 20 years of age or more that daily work at Bayer's site in São Paulo
- Provide written informed consent
Who cannot join
- Employees that will no longer work for Bayer in 30 days
- Employees that are retired from work during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
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.
Read more
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.
- Conditions
- Occupational Health
- Being tested
- Examination and survey
- Keywords
- Worksite, Cardiovascular, Epidemiology, Risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination and surveyBehavioural
Routine medical examination as required by law and follow-up for lifestyle change program
| Study group | Role | What they receive |
|---|---|---|
| Bayer Sao Paulo employees | Workers from Bayer in site Socorro who participate in the trial Receives: Behavioral: Examination and survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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
Measured: Up to 4 weeks after cardiovascular examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational HealthStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055651
- Sponsor's protocol ID
- 17312
- Other IDs
- NN1325BR
- Status last verified
- Nov 2016
- First submitted
- 24 Jan 2014
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Observational Study of Cardiovascular Health Risk Factors in Workers of Bayer S.A. Company in São Paulo
- ClinicalTrials.gov ID
- NCT02055651
- Acronym / sponsor ID
- 17312
- Conditions
- Occupational Health
- Keywords
- Worksite, Cardiovascular, Epidemiology, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bayer Sao Paulo employees | – | Behavioral: Examination and surveyWorkers from Bayer in site Socorro who participate in the trial |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bayer's employees (São Paulo, Brazil)
Key inclusion criteria (2 listed)
- Employees with 20 years of age or more that daily work at Bayer's site in São Paulo
- Provide written informed consent
Key exclusion criteria (2 listed)
- Employees that will no longer work for Bayer in 30 days
- Employees that are retired from work during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination and surveyRoutine medical examination as required by law and follow-up for lifestyle change program | Behavioural | Bayer Sao Paulo employees |
Primary outcome
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]
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Health, run by Bayer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular health metrics on a three-point scale (poor, intermediate, ideal) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.