Clinical trial NCT04686812: Worksite Health Promotion Intervention to Promote Healthy Habits Among Workers From Mexican Companies
Official title: Mexican Institute of Social Security and Companies' Collaboration Model to Promote Workers' Healthy Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: workplace health promotion
intervention
Mexico
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
name: University of California, Los Angeles
First posted: 2020-12-29
Enrollment: 2002
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure from baseline to 6 and 12 months after a worksite health promotion intervention
timeFrame: Baseline, 6 months, and 12 months
measure: Change in body mass index from baseline to 6 and 12 months after a worksite health promotion intervention
timeFrame: Baseline, 6 months, and 12 months
measure: Change in oxygen uptake (VO2max) from baseline to 6 and 12 months after a worksite health promotion intervention
timeFrame: Baseline, 6 months, and 12 months
measure: Change in blood glucose levels from baseline to 6 and 12 months after a worksite health promotion intervention
timeFrame: Baseline, 6 months, and 12 months
measure: Change in blood cholesterol levels from baseline to 6 and 12 months after a worksite health promotion intervention
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Mexicano del Seguro Social
Study officials:
affiliation: University of California, Los Angeles
name: Isabel J Garcia-Rojas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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