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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] 282670 0
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
289367 0
Insulin Resistance (fasting blood sugar, OGTT) 289369 0
Symptoms associated with organophospate exposure:
Weakness
Headache
Nausea
Miosis
Muscle twitch
289372 0
Condition category
Condition code
Public Health 289704 289704 0 0
Health service research
Injuries and Accidents 289706 289706 0 0
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] 287330 0
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] 290137 0
% of participants returning for followup visits
Timepoint [1] 290137 0
Recorded at 3, 6 and 9 weeks after initial health assessment
Primary outcome [2] 290138 0
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] 290138 0
Final reading 10-12 weeks after initial health check (in all participants)
Primary outcome [3] 290139 0
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] 290139 0
Assessed after baseline, 3, 6 and 9 weeks after commencement of the study
Secondary outcome [1] 304005 0
Stress levels are assessed using Kessler K10 questionnaire
Timepoint [1] 304005 0
Beginning of the study
Secondary outcome [2] 304006 0
Mean fasted blood glucose and cholesterol levels (Farmers, Non Farmers). Assessed by capillary blood sampling.
Timepoint [2] 304006 0
Baseline
Secondary outcome [3] 304798 0
Extent of use of personal protective equipment when using agrichemicals. Established through questionnaire.
Timepoint [3] 304798 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1373 0
Western District Health Service - Hamilton - Hamilton
Recruitment postcode(s) [1] 7240 0
3300 - Hamilton

Funding & Sponsors
Funding source category [1] 287720 0
University
Name [1] 287720 0
Deakin University
Address [1] 287720 0
Faculty of Health
Melbourne Burwood Campus
221 Burwood Highway
Burwood
VIC 3125
Country [1] 287720 0
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] 286451 0
Hospital
Name [1] 286451 0
Western District Health Service
Address [1] 286451 0
20 Foster St
Hamilton, VIC 3300
Country [1] 286451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289679 0
Deakin University Human Research Ethics Commitee
Ethics committee address [1] 289679 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [1] 289679 0
Australia
Date submitted for ethics approval [1] 289679 0
24/04/2013
Approval date [1] 289679 0
18/06/2013
Ethics approval number [1] 289679 0
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 39194 0
Dr Jacqueline Cotton
Address 39194 0
National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300
Country 39194 0
Australia
Phone 39194 0
+61 03 5551 8585
Fax 39194 0
Email 39194 0
j.cotton@deakin.edu.au
Contact person for public queries
Name 39195 0
Dr Jacqueline Cotton
Address 39195 0
National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300
Country 39195 0
Australia
Phone 39195 0
+61 03 5551 8585
Fax 39195 0
Email 39195 0
j.cotton@deakin.edu.au
Contact person for scientific queries
Name 39196 0
Dr Jacqueline Cotton
Address 39196 0
National Centre for Farmer Health
PO Box 283
Hamilton VIC 3300
Country 39196 0
Australia
Phone 39196 0
+61 03 5551 8585
Fax 39196 0
Email 39196 0
j.cotton@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary