Cardiovascular Risk FactorsNCT04686812
Worksite Health Promotion Intervention to Promote Healthy Habits Among Workers From Mexican Companies
A study testing Worksite health promotion program in people with Cardiovascular Risk Factors, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The purpose of this study is to explore the effects of a multidisciplinary worksite intervention program on biological cardiovascular risk factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Worksite health promotion program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,002 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jun 2009to 30 Jun 2011
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full-time employees of one of the participating companies
- Willing to participate in the baseline and follow-up health risk assessments and when applicable, in the different elements of the intervention.
Who cannot join
- Not being a full-time employee of the participating companies
- Refusing to participate in the health risk assessments and when applicable, in the different elements of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mexican Institute of Social Security and Companies' Collaboration Model to Promote Workers' Healthy Habits
The purpose of this study is to explore the effects of a multidisciplinary worksite intervention program on biological cardiovascular risk factors.
Read the detailed description
This prospective study consisted of a six-month company-based workplace health promotion intervention trial with a 6- and 12-month follow-up after the start of the intervention. IMSS' researchers promoted participation in this study among affiliated companies located in Mexico City and recruited 2,002 workers from seven different worksites, including a cooking utensils factory, a government public health services department, a metalworking company, a pharmaceutical company, a plastic factory, and a printing company. Companies were selected on the basis of their willingness to engage in the study's activities and consented to be part of either a control (n = 991, baseline and follow-up surveys only) or an intervention group (n = 1011, surveys plus intervention). Employers were presented with the intervention first and if they did not agree to participate, the option to enter the study as a control company was offered second. A health risk assessment (HRA), including a questionnaire and biological measurements (i.e., anthropometric and physiological measurements, as well as blood glucose, total cholesterol, triglycerides, and LDL), was performed at baseline, 6 months, and 1 year after the beginning of the study for both control and intervention groups.
IMSS researchers met in person with the directors of each company to introduce the intervention program and once they obtained authorization to perform the activities, nurses and social workers from the research team were in charge of promoting the intervention throughout the company. They held focus group meetings with workers during the workday, discussing the benefits of physical activity, healthy nutrition, and stress management. They also distributed flyers, displayed posters, and carried out one-on-one interactions whenever possible. As an incentive, they offered workers a complete and confidential physical examination, including blood work for free. They collected all data during the day shift and remained in each of the companies for about a week in order to enroll as many participants as possible but no further efforts were made to reach workers on sick leave or disability. Workers voluntarily participated.
Experts such as occupational physicians, nurses, psychologists, nutritionists, and sports medicine specialists designed the HRA questionnaire at IMSS. It included items on demographic and organizational characteristics, behavioral and biological risk factors for cardiovascular disease, and personal history of diabetes, hypertension, cardiovascular disease, and other self-reported medical conditions as doctors' diagnosis. The questionnaire was distributed among participating workers who completed it at home and submitted it to the research team on the day of their physical evaluation.
The physical examination included anthropometric (i.e., height, weight, waist circumference, and skinfold measurements to assess body fat, muscle, and bone mass), physiological measurements (such as heart rate, blood pressure, maximum oxygen intake), and a finger-stick cholesterol and glucose screening. These measurements and the survey information were used to determine the prevalence of individual cardiovascular risk factors (CVRF) such as age, income, gender, cardiorespiratory fitness, obesity, hypertension, diabetes, and dyslipidemia.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Worksite health promotion program
- Keywords
- workplace health promotion, intervention, Mexico
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worksite health promotion programBehavioural
Also called Wellness intervention
Physical activity, nutrition, and stress management programs
| Study group | Role | What they receive |
|---|---|---|
| Worksite health promotion program | Experimental | Participants had a baseline health risk assessment (HRA) after which they were invited to participate in a workplace health promotion program. The intervention lasted six months and included the following components: nutrition counseling, physical activity, and stress management. HRAs were performed 6 and 12 months after intervention onset. Receives: Behavioral: Worksite health promotion program |
| Control | No intervention | Participants only had a baseline and follow-up health risk assessments at 6 and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure from baseline to 6 and 12 months after a worksite health promotion intervention
Blood pressure was measured manually by two research nurses using a sphygmomanometer and following protocols from the American Heart Association. Workers rested for about 5 minutes before the measurement, which was taken on their left arm while sitting.
Measured: Baseline, 6 months, and 12 months
Change in body mass index from baseline to 6 and 12 months after a worksite health promotion intervention
Weight and height were measured in kg and cm, respectively, using a floor scale with stadiometer (Salter Brecknell brand). Workers were asked to remove their shoes and wore their usual clothing or uniform. Body mass index was calculated by dividing weight in kilograms by height in meters squared.
Measured: Baseline, 6 months, and 12 months
Change in oxygen uptake (VO2max) from baseline to 6 and 12 months after a worksite health promotion intervention
The submaximum heart rate was obtained by applying Manero's protocol, which consisted on stepping up and down an ergometric bench. The frequency of each ascent was calculated as 90 for active workers and 84 for sedentary workers. One minute training was given to workers before the exercise to explain how to step up the bench (six steps to go up and six to come back down). The test lasted 5 minutes and was guided by an electronic metronome that marked the frequency of steps. A trained nurse measured each participant's heart rate by direct auscultation during the first 15 seconds immediately after the 5-minute exercise. This value was multiplied by 4 to obtain the sub-maximum heart rate and logged into a software that applied a correction factor by age and made group comparisons in Manero's nomograph, giving as a result the oxygen uptake in liters per minute.
Measured: Baseline, 6 months, and 12 months
Change in blood glucose levels from baseline to 6 and 12 months after a worksite health promotion intervention
Levels of glucose were measured using a CardioChek® Plus analyzer (CCPA, PTS Diagnostics, model 2009). The materials used to take the test were alcohol swabs, sterile lancets, gloves, test strips, MEMo chip®, and the device CCPA.
Measured: Baseline, 6 months, and 12 months
Change in blood cholesterol levels from baseline to 6 and 12 months after a worksite health promotion intervention
Levels of total cholesterol, LDL, and HDL were measured using a CardioChek® Plus analyzer (CCPA, People, Technology, and Service Diagnostics, model 2009). The materials used to take the test were alcohol swabs, sterile lancets, gloves, test strips, MEMo chip®, and the device CCPA.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start30 Jun 2009
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico, University of California, Los Angeles
- Responsible party
- Principal investigator, Isabel Garcia-Rojas, Instituto Mexicano del Seguro Social
- Investigators
- Isabel J Garcia-Rojas, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686812
- Sponsor's protocol ID
- SALUD-2005/02/14451
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be held in a public repository and Uniform Resource Locator (URL)/accession numbers will be available
Publications
Garcia-Rojas IJ, Choi B, Krause N. Psychosocial job factors and biological cardiovascular risk factors in Mexican workers. Am J Ind Med. 2015 Mar;58(3):331-51. doi: 10.1002/ajim.22410.
PubMed 25678459Garcia Rojas, I. J. (2014). Associations of job strain, isostrain, and job insecurity with cardiovascular risk factors and productivity in Mexican workers. UCLA. ProQuest ID: GarciaRojas_ucla_0031D_10853. Merritt ID: ark:/13030/m5322105. Retrieved from https://escholarship.org/uc/item/2qd9m61x
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mexican Institute of Social Security and Companies' Collaboration Model to Promote Workers' Healthy Habits
- ClinicalTrials.gov ID
- NCT04686812
- Acronym / sponsor ID
- SALUD-2005/02/14451
- Conditions
- Cardiovascular Risk Factors
- Keywords
- workplace health promotion, intervention, Mexico
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,002 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- National Council of Science and Technology, Mexico, University of California, Los Angeles
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 29 Dec 2020 (actual)
- 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.
The purpose of this study is to explore the effects of a multidisciplinary worksite intervention program on biological cardiovascular risk factors.
Detailed description
This prospective study consisted of a six-month company-based workplace health promotion intervention trial with a 6- and 12-month follow-up after the start of the intervention. IMSS' researchers promoted participation in this study among affiliated companies located in Mexico City and recruited 2,002 workers from seven different worksites, including a cooking utensils factory, a government public health services department, a metalworking company, a pharmaceutical company, a plastic factory, and a printing company. Companies were selected on the basis of their willingness to engage in the study's activities and consented to be part of either a control (n = 991, baseline and follow-up surveys only) or an intervention group (n = 1011, surveys plus intervention). Employers were presented with the intervention first and if they did not agree to participate, the option to enter the study as a control company was offered second. A health risk assessment (HRA), including a questionnaire and biological measurements (i.e., anthropometric and physiological measurements, as well as blood glucose, total cholesterol, triglycerides, and LDL), was performed at baseline, 6 months, and 1 year after the beginning of the study for both control and intervention groups.
IMSS researchers met in person with the directors of each company to introduce the intervention program and once they obtained authorization to perform the activities, nurses and social workers from the research team were in charge of promoting the intervention throughout the company. They held focus group meetings with workers during the workday, discussing the benefits of physical activity, healthy nutrition, and stress management. They also distributed flyers, displayed posters, and carried out one-on-one interactions whenever possible. As an incentive, they offered workers a complete and confidential physical examination, including blood work for free. They collected all data during the day shift and remained in each of the companies for about a week in order to enroll as many participants as possible but no further efforts were made to reach workers on sick leave or disability. Workers voluntarily participated.
Experts such as occupational physicians, nurses, psychologists, nutritionists, and sports medicine specialists designed the HRA questionnaire at IMSS. It included items on demographic and organizational characteristics, behavioral and biological risk factors for cardiovascular disease, and personal history of diabetes, hypertension, cardiovascular disease, and other self-reported medical conditions as doctors' diagnosis. The questionnaire was distributed among participating workers who completed it at home and submitted it to the research team on the day of their physical evaluation.
The physical examination included anthropometric (i.e., height, weight, waist circumference, and skinfold measurements to assess body fat, muscle, and bone mass), physiological measurements (such as heart rate, blood pressure, maximum oxygen intake), and a finger-stick cholesterol and glucose screening. These measurements and the survey information were used to determine the prevalence of individual cardiovascular risk factors (CVRF) such as age, income, gender, cardiorespiratory fitness, obesity, hypertension, diabetes, and dyslipidemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Worksite health promotion program | Experimental | Behavioral: Worksite health promotion programParticipants had a baseline health risk assessment (HRA) after which they were invited to participate in a workplace health promotion program. The intervention lasted six months and included the following components: nutrition counseling, physical activity, and stress management. HRAs were performed 6 and 12 months after intervention onset. |
| Control | No intervention | –Participants only had a baseline and follow-up health risk assessments at 6 and 12 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Full-time employees of one of the participating companies
- Willing to participate in the baseline and follow-up health risk assessments and when applicable, in the different elements of the intervention.
Key exclusion criteria (2 listed)
- Not being a full-time employee of the participating companies
- Refusing to participate in the health risk assessments and when applicable, in the different elements of the intervention
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 |
|---|---|---|
| Worksite health promotion programAlso: Wellness interventionPhysical activity, nutrition, and stress management programs | Behavioural | Worksite health promotion program |
Primary outcome
Change in blood pressure from baseline to 6 and 12 months after a worksite health promotion intervention
Time frame: Baseline, 6 months, and 12 months
Blood pressure was measured manually by two research nurses using a sphygmomanometer and following protocols from the American Heart Association. Workers rested for about 5 minutes before the measurement, which was taken on their left arm while sitting.
Change in body mass index from baseline to 6 and 12 months after a worksite health promotion intervention
Time frame: Baseline, 6 months, and 12 months
Weight and height were measured in kg and cm, respectively, using a floor scale with stadiometer (Salter Brecknell brand). Workers were asked to remove their shoes and wore their usual clothing or uniform. Body mass index was calculated by dividing weight in kilograms by height in meters squared.
Change in oxygen uptake (VO2max) from baseline to 6 and 12 months after a worksite health promotion intervention
Time frame: Baseline, 6 months, and 12 months
The submaximum heart rate was obtained by applying Manero's protocol, which consisted on stepping up and down an ergometric bench. The frequency of each ascent was calculated as 90 for active workers and 84 for sedentary workers. One minute training was given to workers before the exercise to explain how to step up the bench (six steps to go up and six to come back down). The test lasted 5 minutes and was guided by an electronic metronome that marked the frequency of steps. A trained nurse measured each participant's heart rate by direct auscultation during the first 15 seconds immediately after the 5-minute exercise. This value was multiplied by 4 to obtain the sub-maximum heart rate and logged into a software that applied a correction factor by age and made group comparisons in Manero's nomograph, giving as a result the oxygen uptake in liters per minute.
Change in blood glucose levels from baseline to 6 and 12 months after a worksite health promotion intervention
Time frame: Baseline, 6 months, and 12 months
Levels of glucose were measured using a CardioChek® Plus analyzer (CCPA, PTS Diagnostics, model 2009). The materials used to take the test were alcohol swabs, sterile lancets, gloves, test strips, MEMo chip®, and the device CCPA.
Change in blood cholesterol levels from baseline to 6 and 12 months after a worksite health promotion intervention
Time frame: Baseline, 6 months, and 12 months
Levels of total cholesterol, LDL, and HDL were measured using a CardioChek® Plus analyzer (CCPA, People, Technology, and Service Diagnostics, model 2009). The materials used to take the test were alcohol swabs, sterile lancets, gloves, test strips, MEMo chip®, and the device CCPA.
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 29 Dec 2020.
- Results publication: PubMed 25678459Garcia-Rojas IJ, Choi B, Krause N. Psychosocial job factors and biological cardiovascular risk factors in Mexican workers. Am J Ind Med. 2015 Mar;58(3):331-51. doi: 10.1002/ajim.22410.
- Results publicationGarcia Rojas, I. J. (2014). Associations of job strain, isostrain, and job insecurity with cardiovascular risk factors and productivity in Mexican workers. UCLA. ProQuest ID: GarciaRojas_ucla_0031D_10853. Merritt ID: ark:/13030/m5322105. Retrieved from https://escholarship.org/uc/item/2qd9m61x
- Individual participant dataSharing planned: Yes. All data will be held in a public repository and Uniform Resource Locator (URL)/accession numbers will be available
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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.
Isabel J Garcia-Rojas, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Worksite health promotion program in people with Cardiovascular Risk Factors, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 29 Dec 2020. 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 Mexico. 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?
Change in blood pressure from baseline to 6 and 12 months after a worksite health promotion intervention (time frame: Baseline, 6 months, and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686812, which also lists 2 linked publications.
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 29 Dec 2020.