This study is a randomized controlled trial. The aim of this study will be to determine the effects of health promotion intervention program to reduce the pesticide exposure among farmers. Design: in the first stage, using quantitative and qualitative methods, a needs assessment will be to reduce exposure to pesticides of behavioral problems farmers. From 54 villages have health houses had most of the problems identified in the needs assessment process, as clusters are used to lottery. For this purpose, the names written and among them will be selected by lottery, in the first five health houses for the control group, five other health houses for the intervention group I and the five other health houses selected for the intervention group II. After entering in health houses to study in the first list of farmers will be provided by health workers and farmers will be selected by simple random sampling among them. Blinding the study was done only for farmers. Setting and conduct: focused interventions to farmers will be in three issue pesticide storage, mixing and use of pesticides (spraying). Eligibility criteria: farmers who do spraying work. Intervention: providing training classes along with the distribution of personal protective equipment will be among farmers. Outcome measure: assess will be for effectiveness of interventions related between the intervention and control groups for determine expected outcomes in two time periods before and three months after intervention. Integrative agent centered questionnaire will be complete via interview. Also for determine exposure farmers to the organophosphate and carbamate pesticides, respectively test measuring the activity of the enzyme acetylcholinesterase (AChE) will be done by method of Ellman in plasma (PChE) and erythrocytes (EChE).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013032312N1
Registration date:2017-03-22, 1396/01/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-22, 1396/01/02
Registrant information
Name
Maryam Afshari
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0090
Email address
m.afshari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- Chancellor of Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of health promotion intervention program to reduce the pesticide exposure among farmers
Public title
The effects of intervention program to reduce the pesticide exposure among farmers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included; farmers who are exposed by organophosphate and carbamate pesticides and the types of pesticides used in agriculture and horticulture, inappropriate use of personal protective equipment (including masks and gloves) and consent to participate in the study.
Exclusion criteria included in this study; migration from the region and non participation in half the envisaged intervention components (including half of the training sessions and tests loss AChE.
Age
From 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
201
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Hamadan University of Medical Science
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.509
Health conditions studied
1
Description of health condition studied
Reduce exposure to pesticides
ICD-10 code
T60
ICD-10 code description
Toxic effect of pesticides
Primary outcomes
1
Description
Activity of the enzyme acetylcholinesterase
Timepoint
Befor and three month after intervention
Method of measurement
Laboratory measurement with method of Ellman
Secondary outcomes
1
Description
Protective behaviors
Timepoint
Befor and three month after intervention
Method of measurement
Integrative agent centered questionnaire
2
Description
Farmers health program
Timepoint
Befor and three month after intervention
Method of measurement
Checklist
3
Description
Constructs of combined health education and health promotion model
Timepoint
Befor and three month after intervention
Method of measurement
Integrative agent centred questionnaire
Intervention groups
1
Description
Third group: control group
Category
N/A
2
Description
First group: agriculture health program for providers+ education
Category
Behavior
3
Description
Second group: agriculture health program for providers+ education+ receive personal protective equipment
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
15 villages have a health center in the city Tuyserkan
Full name of responsible person
Maryam Afshari
Street address
City
Tuyserkan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr saeed Bashirian
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science,Public Health
Full name of responsible person
Maryam Afshari
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
m.afshari@umsha.ac.ir; afshari_m20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science, School of Public Health
Full name of responsible person
Maryam Afshari
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
+98 918 350 2663
Fax
Email
m.afshari@umsha.ac.ir; afshari_m20@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science, Public Health
Full name of responsible person
Maryam Afshari
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
Fax
Email
m.afshari@umsha.ac.ir; afshari_m20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)