- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686812
Worksite Health Promotion Intervention to Promote Healthy Habits Among Workers From Mexican Companies
Mexican Institute of Social Security and Companies' Collaboration Model to Promote Workers' Healthy Habits
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mexico City, Mexico, 06600
- Instituto Mexicano del Seguro Social
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Worksite health promotion program
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.
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Physical activity, nutrition, and stress management programs
Other Names:
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No Intervention: Control
Participants only had a baseline and follow-up health risk assessments at 6 and 12 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months, and 12 months
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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.
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Baseline, 6 months, and 12 months
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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.
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Baseline, 6 months, and 12 months
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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
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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.
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Baseline, 6 months, and 12 months
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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
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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.
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Baseline, 6 months, and 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Isabel J Garcia-Rojas, PhD, University of California, Los Angeles
Publications and helpful links
General 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.
- Garcia 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SALUD-2005/02/14451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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