COM-B Model-based Behavioral Intervention on Safe Pesticide Use and Food Safety Practice Among Farmers

NCT07507994 | Not Yet Recruiting

• 1 other identifier: 4005/2025
• Study Type: interventional
• Target: 572
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

Conditions

Pesticide Exposure; Food Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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

Behavioral: COM-B-Based Behavioral Intervention

Routine agricultural extension services

ACTIVE COMPARATOR

Participants receive routine agricultural extension services

Other: Active Comparator: Routine agricultural extension services

Interventions

COM-B-Based Behavioral Intervention BEHAVIORAL

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

COM-B Behavioral Intervention Group

Active Comparator: Routine agricultural extension services OTHER

Participants will receive routine agricultural extension services and follow-up for 16 weeks

Routine agricultural extension services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahir Dar University: lead

Study Officials

• Higemengist Astatkie, Ph.D.

  Bahir Dar University, Collage of Medicine and Health science

  STUDY DIRECTOR

Central Study Contacts

Amsalu Birara, Master

CONTACT

+251911586869; amsalubirara@yahoo.com

Achenef Motbainor, Ph.D.

CONTACT

+251913036325; motbainor2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the main finding,