NCT04815538

Brief Summary

The prevalence of MetS and its components among industrial workers and its risk factors correlates among them and compare them with those in employees from a nonindustrial setting, and explore the influence of different industries on hematological parameters especially WBCs derangement

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 19, 2021

Last Update Submit

March 24, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Metabolic Syndrome no. among each group

    MetS was defined according to International Diabetes Federation criteria as: central obesity (defined as waist circumference 90 cm for men and 80 cm for women, plus any two of the following four factors: Raised TG level (150 mg/dl or on treatment for lipid abnormality), reduced HDL cholesterol (¼90 cm for men and \>¼80 cm for women and any two of the following four factors: triglycerides \>¼150 mg/ dl, reduced HDL cholesterol (\<40 mg/dl in men and \<50 mg/dl in women or on treatment for lipid abnormality), raised blood pressure (systolic blood pressure 130 mm Hg or diastolic blood pressure 85 mm Hg or on treatment for hypertension),raised fasting plasma glucose (FPG) (FPG100 mg/dl or on treatment for diabetes).

    up to 12 weeks From date of randomization until the date of first documented progression

  • Nutritional health behavior

    nutritional health behavior was obtained using the subscale of Health-Promoting Lifestyle Profile II. Nutritional health behavior included the following nine items: "choose a low-fat diet"; "limit the use of sugars"; "eat servings of bread, cereal, and rice"; "eat servings of fruit"; "eat servings of vegetables"; "eat servings of meat, poultry, fish, dried beans, eggs and nuts"; "eat servings of milk, yogurt or cheese"; "read labels to identify nutrients"; and "eat breakfast." The number of daily servings for each food group was set according to the dietary guidelines, Participants were asked to rate nine items on a four-point Likert scale, ranging from 1 (never) to 4 (routinely). A higher mean score indicated a greater level of participation in nutritional health behavior.

    up to 12 weeks From date of randomization until the date of first documented progression

Secondary Outcomes (1)

  • blood sample for Complete blood picture

    up to 12 weeks From date of randomization until the date of first documented progression

Study Arms (2)

industrial workers

Active workers more than 1 year in petrochemical plant, fertilizer factory , electrical station and food industry

Behavioral: the subscale of Health-Promoting Lifestyle Profile II

control group

office work unexposed

Behavioral: the subscale of Health-Promoting Lifestyle Profile II

Interventions

Nutritional health behavior included the following nine items: "choose a low-fat diet"; "limit the use of sugars"; "eat servings of bread, cereal, and rice"; "eat servings of fruit"; "eat servings of vegetables"; "eat servings of meat, poultry, fish, dietary guidelines

Also known as: Occupational Physical activity
control groupindustrial workers

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

active exposed industrial workers in selected factories

You may qualify if:

  • Active workers more than 1 year in selected plants with matched controls from employee of Assiut University.

You may not qualify if:

  • Workers who had been working for less than 1 year in their petrochemical plants
  • Workers with self-reported and/or diagnosed carcinomas, hematological diseases, and/or immune diseases.
  • Workers taking any medicine in the preceding 2 weeks affecting lipid profile \& blood picture.
  • Workers unwilling to provide biological samples or doing so in insufficient volume.
  • Workers diagnosed MetS and its components before joing the petrochemical industry.
  • Workers with morbid obesity BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Huang JH, Li RH, Huang SL, Sia HK, Lee SS, Wang WH, Tang FC. Relationships between different types of physical activity and metabolic syndrome among Taiwanese workers. Sci Rep. 2017 Oct 23;7(1):13735. doi: 10.1038/s41598-017-13872-5.

    PMID: 29061986BACKGROUND
  • Hidaka T, Hayakawa T, Kakamu T, Kumagai T, Hiruta Y, Hata J, Tsuji M, Fukushima T. Prevalence of Metabolic Syndrome and Its Components among Japanese Workers by Clustered Business Category. PLoS One. 2016 Apr 15;11(4):e0153368. doi: 10.1371/journal.pone.0153368. eCollection 2016.

    PMID: 27082961BACKGROUND
  • Jeong HS. The Relationship between Workplace Environment and Metabolic Syndrome. Int J Occup Environ Med. 2018 Oct;9(4):176-183. doi: 10.15171/ijoem.2018.1346.

    PMID: 30325358BACKGROUND
  • Clementi EA, Talusan A, Vaidyanathan S, Veerappan A, Mikhail M, Ostrofsky D, Crowley G, Kim JS, Kwon S, Nolan A. Metabolic Syndrome and Air Pollution: A Narrative Review of Their Cardiopulmonary Effects. Toxics. 2019 Jan 30;7(1):6. doi: 10.3390/toxics7010006.

    PMID: 30704059BACKGROUND
  • Mini GK, Sarma PS, Thankappan KR. Overweight, the major determinant of metabolic syndrome among industrial workers in Kerala, India: Results of a cross-sectional study. Diabetes Metab Syndr. 2019 Sep-Oct;13(5):3025-3030. doi: 10.1016/j.dsx.2018.07.009. Epub 2018 Jul 17.

    PMID: 30033228BACKGROUND
  • Sajid Jabbar A, Ali ET. Impact of Petroleum Exposure on Some Hematological Indices, Interleukin-6, and Inflammatory Markers of Workers at Petroleum Stations in Basra City. J Environ Public Health. 2020 Aug 4;2020:7693891. doi: 10.1155/2020/7693891. eCollection 2020.

    PMID: 32831856BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Mariam R Elkhayat, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 25, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2022

Study Completion

October 30, 2022

Last Updated

March 26, 2021

Record last verified: 2021-03