Worksite Health Promotion Intervention to Promote Healthy Habits Among Workers From Mexican Companies

December 22, 2020 updated by: Isabel Garcia-Rojas, Instituto Mexicano del Seguro Social

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

2002

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mexico City, Mexico, 06600
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Physical activity, nutrition, and stress management programs
Other Names:
  • Wellness intervention
No Intervention: Control
Participants only had a baseline and follow-up health risk assessments at 6 and 12 months.

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
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.
Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Isabel J Garcia-Rojas, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2009

Primary Completion (Actual)

June 30, 2011

Study Completion (Actual)

June 30, 2011

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SALUD-2005/02/14451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be held in a public repository and Uniform Resource Locator (URL)/accession numbers will be available

IPD Sharing Time Frame

The data will become available on January 31, 2021

IPD Sharing Access Criteria

Information will be shared with peer-reviewers from journals where publications of this study will be submitted and with researchers needing information to include in review articles on the topics covered by this study. Requests for information will be reviewed by the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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