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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06173479
Other study ID # RCT829741
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 11, 2023
Est. completion date June 30, 2024

Study information

Verified date December 2023
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Brief Summary: Purpose: This clinical trial aims to investigate the effect of educational interventions (HeBSaPU) based on the Health Belief Model on safe pesticide use and biomarkers among greenhouse agricultural workers. The main questions it aims to answer are; 1. Compared to the control group, HeBSaPU affects safe pesticide use practices in greenhouse agricultural workers. 2. Compared to the control group, HeBSaPU affects safe pesticide use health beliefs in greenhouse agricultural workers. 3. Compared to the control group, HeBSaPU affects pesticide exposure determined by urine samples in greenhouse agricultural workers. Participants took educational interventions based on Health Belief Model (HBM) sub-dimensions; including educational posters, free personal protective equipment (PPE) incentives, short reminder messages, and demonstration components about correct PPE usage.


Description:

The study aims to determine the effect of Health Belief Model (HBM) based educational interventions on safe pesticide use practices and biomarkers in greenhouse agricultural workers in Antalya, Turkey. This research is a single-blind (participants), superiority randomized controlled trial design with a parallel group. The population of the research will be the greenhouse agricultural workers in the Sarıcasu Village of Antalya Province. In determining the research sample, the "effect of educational interventions on the change in protection behavior" was taken as Hegges g=0.89, and the sample number was calculated as 56 individuals with a 5% type 1 error margin. Considering that there would be losses during the research, it was planned to take 15-20% more of the sample (n=66). On the map obtained from the Geographical Information Systems of Sarıcasu village, the greenhouses were randomized as experimental and control groups with the help of Randomizer.org. Safe Pesticide Use Practices questionnaire, and Safe Pesticide Use Behaviors Health Belief Model Scale will be used to collect data. The variation of individuals' pesticide exposures will be determined by residue determination in urine samples. Pre-testing of the study, taking the first urine samples, and starting the educational interventions will take place in the second week of November. At the end of twelve weeks, it is anticipated that the data collection process will be terminated with the collection of the last tests and the second urine samples in the last week of January. At the end of the research, it is expected that the safe pesticide use behaviors of HBM-based education initiatives will change positively, and the diacyl phosphate metabolite concentrations in the urine will decrease with the effect of this change.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date June 30, 2024
Est. primary completion date January 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Participant inclusion criteria - Age: 18-65 years, inclusive - Being a greenhouse agricultural worker - Being a permanent employee in pesticide-related jobs in selected greenhouses, - No communication-related barriers (language, speaking, understanding, etc.) - Volunteering to participate in research Participant exclusion criteria - Being a seasonal agricultural worker - Being a daily wage worker, - Not dealing with pesticide-related works

Study Design


Intervention

Behavioral:
HeBSaPU
HeBSaPU training content explains the definition of pesticides, their way of entry into the body, and their health effects. Personal protective equipment, personal hygiene behaviors, and safe behaviors regarding the correct and safe use of pesticides were mentioned.

Locations

Country Name City State
Turkey Akdeniz University Antalya Konyaalti

Sponsors (2)

Lead Sponsor Collaborator
Dilek AYAZ The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dialkylphosphates metabolites in urine samples The concentration of four metabolites (Dimethyl phosphate, Diethyl phosphate, O,O-Dimethyl Dithiophosphate, O,O-Diethyl Dithiophosphate) is expected to change in urine samples. For 12-weeks
Primary Safe Pesticide Use Practice Level Safe Pesticide Use Practice Questionare: A minimum of 20 and a maximum of 100 points are obtained from the questionnaire. A higher total score means a higher pesticide safety level. For 12-weeks
Primary Health Beliefs for Safe Pesticide Use Practices Health Belief Model Scale for Safe Pesticide Use Practices: A minimum of 39 and a maximum of 195 points are obtained from the scale. An increase obtained from the scale is interpreted as a positive health belief level. For 12-weeks
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