Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001130459
Ethics application status
Approved
Date submitted
14/07/2016
Date registered
19/08/2016
Date last updated
19/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring exposure of Western Victorian farmers to organophosphate pesticides
Scientific title
In-field Personalised Cholinesterase Assessment Project (In-field PCAP): Monitoring Victorian farmers exposed to agricultural pesticides in workplace
Secondary ID [1] 289502 0
Nil
Universal Trial Number (UTN)
U1111-1184-4753
Trial acronym
In-field PCAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Organophosphate exposure 299201 0
Insulin resistance (Fasting blood sugar) 299202 0
Condition category
Condition code
Public Health 299210 299210 0 0
Health service research
Injuries and Accidents 299211 299211 0 0
Poisoning

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Target Population: Western Victorian farmers and agricultural workers engaged in crop and livestock operations, with self-reported use of agrichemicals and cholinesterase inhibiting insecticides.

By measuring the activity of the enzyme cholinesterase, exposure to organophophates can be identified. Enzyme activity will be monitored every 4 weeks over the 12 months period.

Each participant will receive a baseline health check during the first visit including:
a) Measurements: Height, weight, waist and hip circumference, body fat percentage, blood pressure, pulse rate.
b) Capillary blood sample : Collected using a finger prick, will test for : Fasting blood glucose, establish personal quantitative estimates of both red blood cell ChE and Plasma ChE.
c) Health and Chemical usage survey: Complete chemical use and well being questionnaire

For the subsequent visits, each participant will undergo:
a) Capillary blood sample: Individualised cholinesterase activity level measured , recorded and discussed by registered nurse.
b) Health and Chemical usage survey: Chemical use and well being questionnaire
Intervention code [1] 295093 0
Not applicable
Comparator / control treatment
No control group, due to the personalized nature of cholinesterase monitoring over a period of time
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298717 0
Difference in average cholinesterase activity using a capillary blood sample
Timepoint [1] 298717 0
Assessed at baseline, then monthly for a period of 12 months
Primary outcome [2] 298718 0
Link between cholinesterase activity (assessed using a capillary blood sample) and organophosphate use (self reported)
Timepoint [2] 298718 0
Cholinesterase activity will be assessed at baseline, then monthly for a period of 12 months; data on organophosphate use within the last month at each assessment will be collected
Secondary outcome [1] 325681 0
Stress level assessed using Kessler K10 questionnaire
Timepoint [1] 325681 0
Baseline
Secondary outcome [2] 325682 0
Mean fasting blood glucose assessed by capillary blood sample
Timepoint [2] 325682 0
Baseline
Secondary outcome [3] 325788 0
Mean fasting cholesterol levels assessed by capillary blood sample
Timepoint [3] 325788 0
Baseline

Eligibility
Key inclusion criteria
Farmers and farm workers, who are 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. Competent to decide and have capacity to consent to participate in the study and, attend a health assessment. Live in south west Victoria.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants of under 18 years of age and who have a recent known chemical incident, or are suffering from a known chronic disease or are taking anti-inflammatory drugs or supplements

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
To evaluate if a difference in cholinesterase activity was present in farmers before and after exposure, sample size is determined at the power of 80% (Beta=0.2) with a set at 0.05 for an effect size of one standard deviation. This requires the sample size to be a minimum of 30 farming individuals exposed to pesticides. By considering the probable retention rate (=85%) for a 12-month study, based on previous research in similar populations, the target recruitment number is fixed at a target of minimum of 50 farmers.
All data will be managed and analysed with SPSS, which is a statistical package widely used in quantitative social science research and is suitable for multivariate analyses. 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 the level of <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6163 0
Western District Health Service - Hamilton - Hamilton
Recruitment hospital [2] 6164 0
Western District Health Service - Coleraine - Coleraine
Recruitment hospital [3] 6165 0
Western District Health Service - Penshurst - Penshurst
Recruitment postcode(s) [1] 13601 0
3300 - Hamilton
Recruitment postcode(s) [2] 13894 0
3315 - Coleraine
Recruitment postcode(s) [3] 13895 0
3289 - Penshurst
Recruitment postcode(s) [4] 13896 0
3483 - Birchip

Funding & Sponsors
Funding source category [1] 294055 0
Charities/Societies/Foundations
Name [1] 294055 0
Shepherd Foundation
Country [1] 294055 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Medicine
75 Pigdons Rd, Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 292882 0
Hospital
Name [1] 292882 0
Western District Health Service
Address [1] 292882 0
20 Foster St, Hamilton, VIC, 3300
Country [1] 292882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295469 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 295469 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [1] 295469 0
Australia
Date submitted for ethics approval [1] 295469 0
24/04/2013
Approval date [1] 295469 0
18/06/2013
Ethics approval number [1] 295469 0
2013-100

Summary
Brief summary
Aims:
This study aims to develop the methodology for clinical point of care (POC) sampling to determine the level of exposure to organophosphates (OP’s) by western Victorian farmers.
Significance:
This methodology will test for cholinesterase activity 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 methodology for cholinesterase activity measurement in farmers and the possible integration of POC sampling in farmer health checks. Importantly it will highlight pesticide 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
Public notes

Contacts
Principal investigator
Name 66798 0
Dr Jacqueline Cotton
Address 66798 0
National Centre for Farmer Health
PO Box 283
Hamilton, VIC 3300
Country 66798 0
Australia
Phone 66798 0
+61 3 555 18585
Fax 66798 0
Email 66798 0
[email protected]
Contact person for public queries
Name 66799 0
Dr Jacqueline Cotton
Address 66799 0
National Centre for Farmer Health
PO Box 283
Hamilton, VIC 3300
Country 66799 0
Australia
Phone 66799 0
+61 3 555 18585
Fax 66799 0
Email 66799 0
[email protected]
Contact person for scientific queries
Name 66800 0
Dr Jacqueline Cotton
Address 66800 0
National Centre for Farmer Health
PO Box 283
Hamilton, VIC 3300
Country 66800 0
Australia
Phone 66800 0
+61 3 555 18585
Fax 66800 0
Email 66800 0
[email protected]

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
No additional documents have been identified.