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Trial registered on ANZCTR

Registration number

ACTRN12613001256763

Ethics application status

Approved

Date submitted

20/09/2013

Date registered

15/11/2013

Date last updated

26/03/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Cholinesterase Research Outreach Project (CROP) - Measuring cholinesterase activity of western Victorian farmers

Scientific title

Can cholinesterase monitoring be better integrated into agricultural health clinics to indicate organophosphate exposure in farming and non farming men and women in western Victoria?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1141-9233

Trial acronym

CROP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acetylcholinesterase inhbition

Insulin Resistance (fasting blood sugar, OGTT)

Symptoms associated with organophospate exposure:
Weakness
Headache
Nausea
Miosis
Muscle twitch

Condition category

Condition code

Public Health

Health service research

Injuries and Accidents

Poisoning

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Farmers, farm workers and farm contractors who are exposed to organophosphate pesticides.

By measuring the activity of the enzyme cholinesterase, exposure to organophosphates can be identified. We are particularly interested in working with farmers (male and female) who are currently farming, working with agricultural chemicals. Enzyme activity will be monitored every 2-3 weeks over a 12 week period.

Each participant will receive a health check during the first visit including:
Measurements: Height, weight, waist and hip circumference, body fat percentage, blood pressure, pulse rate.
Capillary blood sample : Collected using a finger prick, will test for : Fasting blood glucose, cholesterol and cholinesterase levels .
Health and Chemical usage survey: Chemical use and well being questionnaire

Intervention code [1]

Not applicable

Comparator / control treatment

Individuals that do not live and/or work on a farm and are self reported not routinely exposed to organophosphate pesticides

Each participant will receive a health check during the first visit including:
Measurements: Height, weight, waist and hip circumference, body fat percentage, blood pressure, pulse rate.
Capillary blood sample : Collected using a finger prick, will test for : Fasting blood glucose, cholesterol and cholinesterase levels .
Health and Chemical usage survey: Chemical use and well being questionnaire.

Enzyme activity will be monitored every 2-3 weeks over a 12 week period.

Control group

Active

Outcomes

Primary outcome [1]

% of participants returning for followup visits

Timepoint [1]

Recorded at 3, 6 and 9 weeks after initial health assessment

Primary outcome [2]

Difference in average Cholinesterse activity between, test (farming) and control (non-farming) individuals.

Blood cholinesterase activity is measured using a fingerprick test (measured by Test-mate ChE Cholinesterase tester system Model 400, and AChE Assay kit Erythrocyte Cholinesterase) to establish a baseline reading (this will need to be repeated three times if organophosphate exposure has taken place). This test is applied to all individuals in the study.

Chemical use is also recorded for all individuals.

Timepoint [2]

Final reading 10-12 weeks after initial health check (in all participants)

Primary outcome [3]

Link between Cholinesterase activity and organophosphate use

Blood cholinesterase activity is measured using a fingerprick test (measured by Test-mate ChE Cholinesterase tester system Model 400, and AChE Assay kit Erythrocyte Cholinesterase) to establish a baseline reading (this will need to be repeated three times if organophosphate exposure has taken place). This test is applied to all individuals in the study.

Chemical use is also recorded for all individuals. Chemical usage surveys are completed comprising of questions specific to: Health and wellbeing, symptoms and medical conditions, chemical use, work and health and safety (use of personal protective equipment).

Timepoint [3]

Assessed after baseline, 3, 6 and 9 weeks after commencement of the study

Secondary outcome [1]

Stress levels are assessed using Kessler K10 questionnaire

Timepoint [1]

Beginning of the study

Secondary outcome [2]

Mean fasted blood glucose and cholesterol levels (Farmers, Non Farmers). Assessed by capillary blood sampling.

Timepoint [2]

Baseline

Secondary outcome [3]

Extent of use of personal protective equipment when using agrichemicals. Established through questionnaire.

Timepoint [3]

Baseline

Eligibility

Key inclusion criteria

Farmers and farm workers:Participants must be routinely working with agrichemicals , particularly those containing organophosphate (AChE inhibiting chemicals), Have not had a previous chemical known incident, are not suffering from a known chronic disorder, not taking anti-inflammatory drugs or supplements. Participants will need to report usage/exposure to OP throughout the course of the study.
Be competent to decide and have capacity to consent to participate in the study and attend a health
assessment.
Live in south west Victoria.

Non - farmers: Participants should not be living or working on a farm and not routinely using agrichemicals.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants that are under the age of 18 yrs. Participants who have a recent known chemical known incident, are suffering from a known chronic disorder or are taking anti-inflammatory drugs or supplements.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Both

Statistical methods / analysis

All data will be managed and analysed within the statistical program SPSS. SPSS is a statistical package widely used in quantitative social science research and is suitable for multivariate analysis.
Data will be analysed using repeated measures (subjects as own controls) within the General Linear Model. Correlation coefficients between pesticide exposure and metabolic variables will be calculated using Pearson’s and Spearman’s correlation as appropriate. P values will be considered statistically significant at P < 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/06/2013

Actual

28/06/2013

Date of last participant enrolment

Anticipated

20/12/2013

Actual

26/02/2014

Date of last data collection

Anticipated

Actual

24/10/2014

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Western District Health Service - Hamilton - Hamilton

Recruitment postcode(s) [1]

3300 - Hamilton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Faculty of Health
Melbourne Burwood Campus
221 Burwood Highway
Burwood
VIC 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

School of Medicine
Geelong Waurn Ponds Campus, Locked Bag 20000,
Geelong, VIC 3220

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Western District Health Service

Address [1]

20 Foster St
Hamilton, VIC 3300

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Commitee

Ethics committee address [1]

Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/04/2013

Approval date [1]

18/06/2013

Ethics approval number [1]

2013100

Summary

Brief summary

Aims:  To develop the methodology for point of care (POC) testing to determine the level of exposure to organophosphates (OP’s) by western Victorian farmers. Significance: This methodology will test for cholinesterase activity (enzyme that is inhibited by organophosphates) and provide the basis for future research work by identifying the potential chemical exposure pathways of individuals most at risk in farming communities. 

Expected Outcomes: The study will provide a validated methodology for cholinesterase activity measurement in farmers and the integration of this testing in farmer health checks. Importantly, it will highlight insecticide contact as a risk for farmers, leading to further research to quantify pesticide exposure both on the farm and in the home of farming families.

Trial website

www.farmerhealth.org.au

Trial related presentations / publications

Cotton, Jacquie, Brumby, Susan, Lewandowski, Paul, Calvano, Adrian, (2014). Cholinesterase Research Outreach Project (CROP) – Measuring Cholinesterase Activity of Australian Farmers, Journal of Agromedicine, vol. 19, no. 2, pp. 210-211. https://www.tandfonline.com/doi/full/10.1080/1059924X.2014.889628#.U5knlmSSz88 

Cotton, J., Lewandowski, P., Brumby, S. (2015) Cholinesterase Research Outreach Project (CROP): measuring cholinesterase activity and pesticide use in an agricultural community. BMC Public Health, vol 15, August, pp. 748-753 https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-2076-8

Public notes

Contacts

Principal investigator

Name

Dr Jacqueline Cotton

Address

National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300

Country

Australia

Phone

+61 03 5551 8585

Fax

j.cotton@deakin.edu.au

Contact person for public queries

Name

Jacqueline Cotton

Address

National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300

Country

Australia

Phone

+61 03 5551 8585

Fax

j.cotton@deakin.edu.au

Contact person for scientific queries

Name

Jacqueline Cotton

Address

National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300

Country

Australia

Phone

+61 03 5551 8585

Fax

j.cotton@deakin.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cholinesterase Research Outreach Project (CROP): measuring cholinesterase activity and pesticide use in an agricultural community.	2015	https://dx.doi.org/10.1186/s12889-015-2076-8
Embase	Cholinesterase research outreach project (CROP): point of care cholinesterase measurement in an Australian agricultural community.	2018	https://dx.doi.org/10.1186/s12940-018-0374-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

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