NCT03678519

Brief Summary

Flour milling is from the oldest trade industry. Several problems arise during functioning and maintenance operations. Production process involves the breakdown of grains to separate their outer covering and inner endosperm grinding to fine flour particles. Workers are at substantial risk with two main problems causing severe health issues and accidents. The first is the improper flour milling process including intake and final products collection systems. The second is the unawareness and unavailability of PPE.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

September 17, 2018

Last Update Submit

August 10, 2020

Conditions

Occupational Exposure

Outcome Measures

Primary Outcomes (1)

  • Detect number of workers who have occupational diseases

    6 months

Secondary Outcomes (1)

  • Number of patients who have declined pulmonary function tests

    6 months

Study Arms (1)

Exposed workers

Flour mills workers exposed to health hazards

Diagnostic Test: Pulmonary function test

Interventions

Pulmonary function testDIAGNOSTIC_TEST

Pulmonary Function tests using Spirometry. It will show following indices of ventilatory functions: Forced vital capacity (FVC), Forced expiratory volume in the 1st second (FEV1) and Forced expiratory volume in the 1st second as a percentage of the Forced vital capacity (FEV1/FVC %).

Exposed workers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Flour Mills Workers, Assiut

Workers in flour mills

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (8)

  • Nieva G, Comin M, Valero S, Bruguera E. Cigarette dependence and depressive symptoms as predictors of smoking status at five-year follow-up after a workplace smoking cessation program. Addict Behav. 2017 Oct;73:9-15. doi: 10.1016/j.addbeh.2017.04.003. Epub 2017 Apr 3.

    PMID: 28431293BACKGROUND

  • Meo SA, Al-Drees AM. Lung function among non-smoking wheat flour mill workers. Int J Occup Med Environ Health. 2005;18(3):259-64.

    PMID: 16411565BACKGROUND

  • Neghab M, Soltanzadeh A, Alipour A, Hasanzadeh J, Alipour H. Respiratory morbidity induced by occupational inhalation exposure to high concentrations of wheat flour dust. Int J Occup Saf Ergon. 2012;18(4):563-9. doi: 10.1080/10803548.2012.11076960.

    PMID: 23294661BACKGROUND

  • Wang CP, Ma SJ, Xu XF, Wang JF, Mei CZ, Yang GH. The prevalence of household second-hand smoke exposure and its correlated factors in six counties of China. Tob Control. 2009 Apr;18(2):121-6. doi: 10.1136/tc.2008.024836. Epub 2009 Jan 8.

    PMID: 19131456BACKGROUND

  • Fouad H, Awa FE, Naga RA, Emam AH, Labib S, Palipudi KM, Andes LJ, Asma S, Talley B. Prevalence of tobacco use among adults in Egypt, 2009. Glob Health Promot. 2016 Jun;23(2 Suppl):38-47. doi: 10.1177/1757975913499801. Epub 2013 Sep 16.

    PMID: 24042971BACKGROUND

  • Abdullah AS, Driezen P, Quah AC, Nargis N, Fong GT. Predictors of smoking cessation behavior among Bangladeshi adults: findings from ITC Bangladesh survey. Tob Induc Dis. 2015 Aug 11;13(1):23. doi: 10.1186/s12971-015-0050-y. eCollection 2015.

    PMID: 26261450BACKGROUND

  • Brown CRH, Forster S, Duka T. Goal-driven attentional capture by appetitive and aversive smoking-related cues in nicotine-dependent smokers. Drug Alcohol Depend. 2018 Sep 1;190:209-215. doi: 10.1016/j.drugalcdep.2018.06.011. Epub 2018 Jul 19.

    PMID: 30055425BACKGROUND

  • Massin N, Bohadana AB, Wild P, Kolopp-Sarda MN, Toamain JP. Airway responsiveness to methacholine, respiratory symptoms, and dust exposure levels in grain and flour mill workers in eastern France. Am J Ind Med. 1995 Jun;27(6):859-69. doi: 10.1002/ajim.4700270609.

    PMID: 7645579BACKGROUND

MeSH Terms

Interventions

Respiratory Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Hussein H Zayet, Professor

CONTACT

01063885982drzayet@yaho..com

Shimaa A Mohammed, M.D

CONTACT

01000525137Shima_dola@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

EG(1)