NCT04686812

Brief Summary

The purpose of this study is to explore the effects of a multidisciplinary worksite intervention program on biological cardiovascular risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,002

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2011

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 13, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

workplace health promotioninterventionMexico

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline, 6 months, and 12 months

Study Arms (2)

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.

Behavioral: Worksite health promotion program

Control

NO INTERVENTION

Participants only had a baseline and follow-up health risk assessments at 6 and 12 months.

Interventions

Physical activity, nutrition, and stress management programs

Also known as: Wellness intervention
Worksite health promotion program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, 06600, Mexico

Location

Related Publications (2)

  • 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

    RESULT

Study Officials

  • Isabel J Garcia-Rojas, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical programs coordinator

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 29, 2020

Study Start

June 30, 2009

Primary Completion

June 30, 2011

Study Completion

June 30, 2011

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will become available on January 31, 2021
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.
More information

Locations