Exposure OccupationalHeBSaPUNCT06173479
Health Belief Model-Based Educational Intervention on Safe Pesticide Use and Biomarkers in Agricultural Workers
A study testing HeBSaPU in people with Exposure Occupational and Safety Issues, run by Dilek AYAZ at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure Occupational, Safety Issues, Health Behavior
- What is being tested?
- HeBSaPU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Health Belief Model-Based Educational Intervention (HeBSaPU) on Safe Pesticide Use Practices and Biomarkers in Greenhouse Agriculture Workers in Antalya, Turkey
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;
Read more
- Compared to the control group, HeBSaPU affects safe pesticide use practices in greenhouse agricultural workers.
- Compared to the control group, HeBSaPU affects safe pesticide use health beliefs in greenhouse agricultural workers.
- 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.
Read the detailed 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.
- Conditions
- Exposure Occupational, Safety Issues, Health Behavior, Nurse's Role
- Being tested
- HeBSaPU
- Keywords
- greenhouse agricultural workers, pesticide exposure, health belief model, educational interventions
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeBSaPUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HeBSaPU | Experimental | HeBSaPU is an acronym for educational interventions for safe pesticide use based on the health belief model. The HeBSaPU arm will get interventions for 12 weeks. HeBSaPU include educational posters, free personal protective equipment (PPE) incentives, reminder short messages, and demonstration components about correct PPE usage. Receives: Behavioral: HeBSaPU |
| Control | Active comparator | The control arm will not take any interventions. Receives: Behavioral: HeBSaPU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 12-weeks
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.
Measured: For 12-weeks
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.
Measured: For 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start11 Nov 2023
- Primary completion28 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure OccupationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, single-blind experimental design with a pretest-posttest control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilek AYAZ
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Dilek AYAZ, Akdeniz University
- Investigators
- Dilan Akın, Study chair, The Scientific and Technological Research Council of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173479
- Sponsor's protocol ID
- RCT829741
- Acronym
- HeBSaPU
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Health Belief Model-Based Educational Intervention (HeBSaPU) on Safe Pesticide Use Practices and Biomarkers in Greenhouse Agriculture Workers in Antalya, Turkey
- ClinicalTrials.gov ID
- NCT06173479
- Acronym / sponsor ID
- HeBSaPU / RCT829741
- Conditions
- Exposure Occupational, Safety Issues, Health Behavior, Nurse's Role
- Keywords
- greenhouse agricultural workers, pesticide exposure, health belief model, educational interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dilek AYAZUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 28 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Compared to the control group, HeBSaPU affects safe pesticide use practices in greenhouse agricultural workers.
- Compared to the control group, HeBSaPU affects safe pesticide use health beliefs in greenhouse agricultural workers.
- 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled, single-blind experimental design with a pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| HeBSaPU | Experimental | Behavioral: HeBSaPUHeBSaPU is an acronym for educational interventions for safe pesticide use based on the health belief model. The HeBSaPU arm will get interventions for 12 weeks. HeBSaPU include educational posters, free personal protective equipment (PPE) incentives, reminder short messages, and demonstration components about correct PPE usage. |
| Control | Active comparator | Behavioral: HeBSaPUThe control arm will not take any interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeBSaPUHeBSaPU 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. | Behavioural | Control, HeBSaPU |
Primary outcome
Dialkylphosphates metabolites in urine samples
Time frame: For 12-weeks
The concentration of four metabolites (Dimethyl phosphate, Diethyl phosphate, O,O-Dimethyl Dithiophosphate, O,O-Diethyl Dithiophosphate) is expected to change in urine samples.
Safe Pesticide Use Practice Level
Time frame: For 12-weeks
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.
Health Beliefs for Safe Pesticide Use Practices
Time frame: For 12-weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilan Akın study chair
The Scientific and Technological Research Council of Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeBSaPU in people with Exposure Occupational and Safety Issues, run by Dilek AYAZ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialkylphosphates metabolites in urine samples (time frame: For 12-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.