Meatsafe Food Storage and Diarrhea Prevention Trial in Urban Bangladesh

NCT ID: NCT07332078

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-11
• Study Completion Date: 2024-11-30

Brief Summary

The goal of this clinical trial was to evaluate whether a simple household food storage cabinet called a "meatsafe" could reduce bacterial contamination of complementary foods and decrease diarrhea among children aged 6 to 24 months living in low-income settlements of Dhaka, Bangladesh.The study compared households that received a meatsafe and one-time food storage education with households that continued their usual practices. Participating caregivers completed surveys; provided stored food samples for microbiological testing; answered questions about recent child illness; and took part in spot checks of household hygiene and meatsafe use. The trial generated evidence on whether a low-cost and practical tool could help keep children's food safer and reduce diarrheal disease in settings without reliable refrigeration.

Detailed Description

Diarrhea remained a major cause of illness and death among children under five years old in low- and middle-income countries (LMICs). In Bangladesh, complementary foods for young children were frequently contaminated with Escherichia coli (E. coli). Storing food uncovered exposed it to contamination from flies, dust, animals, and hands. Existing water, sanitation, and hygiene (WASH) programs did not directly address food hygiene within the home. This randomized controlled trial (RCT) tested whether a low-cost, mesh-covered food storage cabinet ("meatsafe") could reduce microbial contamination of cooked food in urban settlements in Dhaka. Meatsafes were commercially available in local markets and familiar to many households. A total of 290 households living in the Mirpur and Korail settlements were enrolled. Each household had at least one child aged 6 to 24 months. The protocol originally anticipated enrolling 252 households, but 290 were enrolled to maintain balanced allocation and mitigate attrition. Households were randomly assigned to the intervention or control group. Study staff completed follow-up visits every two weeks through Week 10 (five post-intervention follow-ups). Households in the control group did not receive a meatsafe or food hygiene education and continued their usual food storage practices. Households in the intervention group received a free meatsafe and one-time, in-person education on safe food storage and hygiene, along with an illustrated handout to display in the home. Participating households completed surveys on demographics, hygiene behaviors, child feeding, and health; provided stored food samples that were tested for E. coli using culture plating with colony-forming units per gram (CFU/g) enumeration; reported any child diarrhea in the previous seven days; and participated in spot checks of household hygiene and meatsafe use. The primary outcome was the prevalence of complementary food samples with >= 100 CFU/g of E. coli. Secondary outcomes included caregiver-reported diarrhea, dietary diversity, snack and street-food consumption, and measures of meatsafe use and functionality. This study produced evidence on whether providing meatsafes could improve food safety and reduce diarrheal disease among young children in dense urban communities.

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Meatsafe Arm

Households received a low-cost, mesh-covered food storage cabinet ("meatsafe") and one-time, in-person education on safe food storage and hygiene. Caregivers also received an illustrated handout to display in the home.

Group Type: EXPERIMENTAL

Meatsafe Food Storage Cabinet

Intervention Type: DEVICE

A wire-mesh cabinet for storing cooked food. Designed to prevent contamination from flies, dust, animals, and handling. Distributed with an educational handout and verbal instruction on safe food storage.

Control Arm

Households did not receive a meatsafe or safe storage education and continued their usual food preparation and storage practices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meatsafe Food Storage Cabinet

A wire-mesh cabinet for storing cooked food. Designed to prevent contamination from flies, dust, animals, and handling. Distributed with an educational handout and verbal instruction on safe food storage.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Household had at least one child aged 6 to 24 months.
• Adult caregiver aged 18 years or older, responsible for child feeding, provided informed consent.
• Household had lived in the study area for at least 6 months and expected to remain for at least 6 additional months.
• Caregiver demonstrated willingness to comply with the assigned intervention or control.

Exclusion Criteria

• Household owned a functional meatsafe or refrigerator.
• Household planned relocation outside the study area within 6 months.
• Caregiver did not provide informed consent.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

092000310-UCB-0310

Identifier Type: -

Identifier Source: org_study_id