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)

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.

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

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.

After publication of the main finding,

Given the nature of the behavioral intervention based on the COM-B model, blinding of participants and intervention facilitators will not be possible. However, to minimize assessment bias, data collectors and outcome assessors will remain blinded to the allocation status of the clusters. Furthermore, data analysts will conduct the primary statistical analysis using coded group identifiers.