Pesticide ExposureNCT07507994
COM-B Model-based Behavioral Intervention on Safe Pesticide Use and Food Safety Practice Among Farmers
A study testing COM-B-Based Behavioral Intervention and Active Comparator: Routine agricultural extension services in people with Pesticide Exposure and Food Safety, run by Bahir Dar University.
Trial summary
This study evaluates the effectiveness of a COM-B-based behavioral intervention to improve safe pesticide use and food safety practices among smallholder farmers in Ethiopia, using a cluster-randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pesticide Exposure, Food Safety
- What is being tested?
- COM-B-Based Behavioral Intervention and Active Comparator: Routine agricultural extension services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Participants will be eligible for inclusion if they meet the following criteria:
- Farmers actively engaged in crop or produce farming intended for human consumption
- Individuals regularly involved in agricultural activities, including pesticide handling or application
- Household heads, primary farm operators, or household members responsible for managing agricultural activities
- Individuals who have resided in the study area (North Mecha or Fogera districts) for at least six months or one farming season
- Adults aged 18 years or older
Exclusion Criteria: Participants will be excluded if they meet any of the following conditions:
- Individuals not involved in crop production for human consumption
- Farmers without an operational role in agricultural activities
- Individuals not regularly engaged in farming activities or without experience in pesticide handling or application
- Residents who have lived in the selected Kebele for less than six months
- Individuals currently participating in another similar intervention program
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COM-B Model-based Behavioral Intervention on Safe Pesticide Use and Food Safety Practice Among Farmers in the North Mecha and Fogera Districts: a Randomized Controlled Trial
This study evaluates the effectiveness of a COM-B-based behavioral intervention to improve safe pesticide use and food safety practices among smallholder farmers in Ethiopia, using a cluster-randomized controlled trial design. A cluster-randomized controlled trial will be conducted in the North Mecha and Fogera districts. A total of 22 clusters (kebeles) will be randomly selected and allocated to intervention or control arms.
Approximately 572 eligible farmers will be enrolled. The intervention will last 12 weeks, followed by a 4-week follow-up (total 16 weeks).
Study Design: Interventional, Randomized, Parallel Assignment, Single-blind (assessor)
Read the detailed description
Pesticide use and food safety practices are critical public health concerns in Ethiopia, particularly among smallholder farmers who face frequent exposure to hazardous chemicals and unsafe food handling conditions. Improper pesticide use, including failure to follow label instructions, inadequate use of personal protective equipment (PPE), unsafe storage and disposal, and application under inappropriate environmental conditions, contributes to acute pesticide poisoning and long-term health effects. In addition, poor hygienic practices during the handling, storage, and transportation of agricultural produce increase the risk of food contamination and foodborne diseases.
Despite growing evidence of these risks, most interventions have primarily focused on knowledge dissemination and regulatory enforcement, with limited success in achieving sustained behavioral change. Safe pesticide use and food safety practices are complex behaviors influenced by multiple interacting factors, including capability (knowledge and skills), opportunity (access to resources and supportive environments), and motivation (beliefs, intentions, and habits).
This study applies the Capability, Opportunity, and Motivation-Behavior (COM-B) model as a theoretical framework to design and evaluate a comprehensive behavioral intervention targeting these determinants. The intervention aims to improve farmers' knowledge and practical skills, enhance access to enabling resources and social support, and strengthen motivation through risk communication, goal setting, and behavioral reinforcement strategies.
A cluster randomized controlled trial will be conducted among smallholder farmers in the Fogera and North Mecha districts of the Amhara Region, Ethiopia. A total of 22 clusters (villages) will be randomly selected and allocated to intervention or control arms with proportional representation from each district. Eligible farmers within selected clusters will be enrolled, yielding a total sample size of approximately 572 participants.
The intervention group will receive a structured COM-B-based behavioral intervention delivered over 12 weeks in three monthly cycles. Each cycle comprises four core sessions (approximately 4 hours each) delivered intensively within the first week of the month (Weeks 1, 5, and 9), resulting in 16 contact hours per cycle and a total of approximately 48 contact hours. The sessions target key behavioral domains: (1) enhancing capability through participatory education, demonstrations, and hands-on training; (2) creating supportive opportunities through community engagement, peer learning, and linkage with extension services; (3) strengthening motivation through goal setting, reflection, and behavioral reinforcement; and (4) promoting practice, integration, and feedback to facilitate real-life application.
To reinforce behavior change, follow-up monitoring and supportive supervision will be conducted during the remaining weeks of each cycle through field visits, on-site coaching, group discussions, and behavioral review sessions. These activities aim to provide technical support, identify and address contextual barriers, and strengthen adherence to recommended practices. Following completion of the intervention, an additional 4-week follow-up period will be implemented to assess the translation of learned behaviors into routine practice, after which the endline assessment will be conducted.
The control group will receive routine agricultural and health extension services without exposure to the structured intervention.
Data will be collected at baseline and at 16 weeks post-enrollment (including the 12-week intervention and 4-week follow-up period). The primary outcomes are safe pesticide use practices and food safety practices, measured using structured composite indices. Secondary outcomes include self-reported acute pesticide poisoning symptoms and behavioral determinants aligned with the COM-B framework.
The effectiveness of the intervention will be evaluated using a cluster-level analytical approach that accounts for intra-cluster correlation and repeated measurements. Analyses will follow the intention-to-treat principle, and intervention effects will be estimated using appropriate regression models, such as generalized estimating equations and difference-in-differences approaches, while controlling for potential confounders.
This study is expected to generate robust evidence on the effectiveness of a theory-driven behavioral intervention in improving pesticide safety and food safety practices among smallholder farmers. The findings will contribute to the limited body of randomized controlled trial evidence in agricultural public health and provide practical guidance for designing scalable, behaviorally informed interventions to reduce pesticide-related health risks and improve food safety in low- and middle-income countries.
- Conditions
- Pesticide Exposure, Food Safety
- Being tested
- COM-B-Based Behavioral Intervention, Active Comparator: Routine agricultural extension services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM-B-Based Behavioral InterventionBehavioural
A structured COM-B-based behavioral intervention follows up to 16 weeks, including education, skills training, practical demonstrations, environmental support, and motivational strategies to improve safe pesticide use and food safety practices among farmers, including follow-up visits for reinforcement
Active Comparator: Routine agricultural extension servicesOther
Participants will receive routine agricultural extension services and follow-up for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| COM-B Behavioral Intervention Group | Experimental | Participants receive routine agricultural extension services plus a structured COM-B-based behavioral intervention aimed at improving the safe pesticide use and food safety practices Receives: Behavioral: COM-B-Based Behavioral Intervention |
| Routine agricultural extension services | Active comparator | Participants receive routine agricultural extension services Receives: Other: Active Comparator: Routine agricultural extension services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe pesticide use
Safe pesticide use practices will be assessed using a 31-item structured questionnaire measuring adherence to recommended pesticide handling and application practices, including use of labeled pesticides, compliance with dosage and timing instructions, use of personal protective equipment (PPE), safe storage, proper disposal of pesticide containers, and avoidance of pesticide application under unsafe weather conditions. Each item will be scored as 1 (practice followed) or 0 (not followed), and summed to generate a composite score ranging from 0 to 31, with higher scores indicating better adherence to safe pesticide practices.
Measured: Participants will be assessed at baseline (prior to intervention) and followed for a total of 16 weeks, including a 12-week intervention period and an 4-week post-intervention follow-up.
Secondary outcomes (1)
Food safety practice
Food safety practices will be assessed using a 19-item structured questionnaire measuring adherence to recommended hygienic practices during handling, storage, and transportation of agricultural produce. The assessment includes hand and face washing before handling produce, use of clean equipment and storage facilities, separation of pesticides from food, hygienic harvesting and transportation, and adherence to pre-harvest intervals. Each item will be scored as 1 (practice followed) or 0 (not followed), and summed to generate a composite score ranging from 0 to 19, with higher scores indicating better food safety practices.
Measured: Participants will be assessed at baseline (prior to intervention) and followed for a total of 16 weeks, including a 12-week intervention period and an 4-week post-intervention follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide ExposureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial (RCT) design with a parallel, two-arm (intervention and control) structure conducted among farmers in the North Mecha and Fogera districts
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amsalu Birara, Bahir Dar University
- Investigators
- Higemengist Astatkie, Ph.D., Study director, Bahir Dar University, Collage of Medicine and Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507994
- Sponsor's protocol ID
- 4005/2025
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to qualified researchers upon reasonable request and submission of a detailed research proposal, including study objectives, methodology, and analysis plan. Access will be subject to review and approval by the Principal Investigator. A formal data sharing agreement must be signed prior to data release, ensuring that the data are used solely for the approved purpose, that participant confidentiality is strictly maintained, and that no attempts are made to re-identify participants.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COM-B Model-based Behavioral Intervention on Safe Pesticide Use and Food Safety Practice Among Farmers in the North Mecha and Fogera Districts: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07507994
- Acronym / sponsor ID
- 4005/2025
- Conditions
- Pesticide Exposure, Food Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (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.
This study evaluates the effectiveness of a COM-B-based behavioral intervention to improve safe pesticide use and food safety practices among smallholder farmers in Ethiopia, using a cluster-randomized controlled trial design. A cluster-randomized controlled trial will be conducted in the North Mecha and Fogera districts. A total of 22 clusters (kebeles) will be randomly selected and allocated to intervention or control arms.
Approximately 572 eligible farmers will be enrolled. The intervention will last 12 weeks, followed by a 4-week follow-up (total 16 weeks).
Study Design: Interventional, Randomized, Parallel Assignment, Single-blind (assessor)
Detailed description
Pesticide use and food safety practices are critical public health concerns in Ethiopia, particularly among smallholder farmers who face frequent exposure to hazardous chemicals and unsafe food handling conditions. Improper pesticide use, including failure to follow label instructions, inadequate use of personal protective equipment (PPE), unsafe storage and disposal, and application under inappropriate environmental conditions, contributes to acute pesticide poisoning and long-term health effects. In addition, poor hygienic practices during the handling, storage, and transportation of agricultural produce increase the risk of food contamination and foodborne diseases.
Despite growing evidence of these risks, most interventions have primarily focused on knowledge dissemination and regulatory enforcement, with limited success in achieving sustained behavioral change. Safe pesticide use and food safety practices are complex behaviors influenced by multiple interacting factors, including capability (knowledge and skills), opportunity (access to resources and supportive environments), and motivation (beliefs, intentions, and habits).
This study applies the Capability, Opportunity, and Motivation-Behavior (COM-B) model as a theoretical framework to design and evaluate a comprehensive behavioral intervention targeting these determinants. The intervention aims to improve farmers' knowledge and practical skills, enhance access to enabling resources and social support, and strengthen motivation through risk communication, goal setting, and behavioral reinforcement strategies.
A cluster randomized controlled trial will be conducted among smallholder farmers in the Fogera and North Mecha districts of the Amhara Region, Ethiopia. A total of 22 clusters (villages) will be randomly selected and allocated to intervention or control arms with proportional representation from each district. Eligible farmers within selected clusters will be enrolled, yielding a total sample size of approximately 572 participants.
The intervention group will receive a structured COM-B-based behavioral intervention delivered over 12 weeks in three monthly cycles. Each cycle comprises four core sessions (approximately 4 hours each) delivered intensively within the first week of the month (Weeks 1, 5, and 9), resulting in 16 contact hours per cycle and a total of approximately 48 contact hours. The sessions target key behavioral domains: (1) enhancing capability through participatory education, demonstrations, and hands-on training; (2) creating supportive opportunities through community engagement, peer learning, and linkage with extension services; (3) strengthening motivation through goal setting, reflection, and behavioral reinforcement; and (4) promoting practice, integration, and feedback to facilitate real-life application.
To reinforce behavior change, follow-up monitoring and supportive supervision will be conducted during the remaining weeks of each cycle through field visits, on-site coaching, group discussions, and behavioral review sessions. These activities aim to provide technical support, identify and address contextual barriers, and strengthen adherence to recommended practices. Following completion of the intervention, an additional 4-week follow-up period will be implemented to assess the translation of learned behaviors into routine practice, after which the endline assessment will be conducted.
The control group will receive routine agricultural and health extension services without exposure to the structured intervention.
Data will be collected at baseline and at 16 weeks post-enrollment (including the 12-week intervention and 4-week follow-up period). The primary outcomes are safe pesticide use practices and food safety practices, measured using structured composite indices. Secondary outcomes include self-reported acute pesticide poisoning symptoms and behavioral determinants aligned with the COM-B framework.
The effectiveness of the intervention will be evaluated using a cluster-level analytical approach that accounts for intra-cluster correlation and repeated measurements. Analyses will follow the intention-to-treat principle, and intervention effects will be estimated using appropriate regression models, such as generalized estimating equations and difference-in-differences approaches, while controlling for potential confounders.
This study is expected to generate robust evidence on the effectiveness of a theory-driven behavioral intervention in improving pesticide safety and food safety practices among smallholder farmers. The findings will contribute to the limited body of randomized controlled trial evidence in agricultural public health and provide practical guidance for designing scalable, behaviorally informed interventions to reduce pesticide-related health risks and improve food safety in low- and middle-income countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial (RCT) design with a parallel, two-arm (intervention and control) structure conducted among farmers in the North Mecha and Fogera districts
| Arm | Type | Receives |
|---|---|---|
| COM-B Behavioral Intervention Group | Experimental | Behavioral: COM-B-Based Behavioral InterventionParticipants receive routine agricultural extension services plus a structured COM-B-based behavioral intervention aimed at improving the safe pesticide use and food safety practices |
| Routine agricultural extension services | Active comparator | Other: Active Comparator: Routine agricultural extension servicesParticipants receive routine agricultural extension services |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| COM-B-Based Behavioral InterventionA structured COM-B-based behavioral intervention follows up to 16 weeks, including education, skills training, practical demonstrations, environmental support, and motivational strategies to improve safe pesticide use and food safety practices among farmers, including follow-up visits for reinforcement | Behavioural | COM-B Behavioral Intervention Group |
| Active Comparator: Routine agricultural extension servicesParticipants will receive routine agricultural extension services and follow-up for 16 weeks | Other | Routine agricultural extension services |
Primary outcome
Safe pesticide use
Time frame: Participants will be assessed at baseline (prior to intervention) and followed for a total of 16 weeks, including a 12-week intervention period and an 4-week post-intervention follow-up.
Safe pesticide use practices will be assessed using a 31-item structured questionnaire measuring adherence to recommended pesticide handling and application practices, including use of labeled pesticides, compliance with dosage and timing instructions, use of personal protective equipment (PPE), safe storage, proper disposal of pesticide containers, and avoidance of pesticide application under unsafe weather conditions. Each item will be scored as 1 (practice followed) or 0 (not followed), and summed to generate a composite score ranging from 0 to 31, with higher scores indicating better adherence to safe pesticide practices.
1 secondary outcome
Food safety practice
Time frame: Participants will be assessed at baseline (prior to intervention) and followed for a total of 16 weeks, including a 12-week intervention period and an 4-week post-intervention follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to qualified researchers upon reasonable request and submission of a detailed research proposal, including study objectives, methodology, and analysis plan. Access will be subject to review and approval by the Principal Investigator. A formal data sharing agreement must be signed prior to data release, ensuring that the data are used solely for the approved purpose, that participant confidentiality is strictly maintained, and that no attempts are made to re-identify participants.
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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.
Higemengist Astatkie, Ph.D. study director
Bahir Dar University, Collage of Medicine and Health science
Questions about this trial
What is this clinical trial studying?
A study testing COM-B-Based Behavioral Intervention and Active Comparator: Routine agricultural extension services in people with Pesticide Exposure and Food Safety, run by Bahir Dar University.
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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amsalu Birara, Master (+251911586869, amsalubirara@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe pesticide use (time frame: Participants will be assessed at baseline (prior to intervention) and followed for a total of 16 weeks, including a 12-week intervention period and an 4-week post-intervention follow-up.). 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 2 Apr 2026.