Meatsafe Food Storage and Diarrhea Prevention Trial in Urban Bangladesh

NCT07332078 | Completed

• 1 other identifier: 092000310-UCB-0310
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

Food Safety; Complementary Foods; Food Hygiene; Safe Food Storage; Meatsafe; Bangladesh; Urban Slum; Low- and Middle-Income Countries (LMICs); WASH (Water, Sanitation, and Hygiene); Enteric Pathogens; Randomized Controlled Trial (RCT); Low-Cost Intervention; Complementary Feeding; Public Health Intervention; Foodborne Pathogens; Enteric Infection; Diarrheal Disease; Fecal-Oral Transmission; Microbial Contamination; Foodborne Illness; Childhood Diarrhea Prevention; Child Health; Escherichia coli (E. coli); Nutrition; Hygiene

Outcome Measures

Primary Outcomes (1)

• Prevalence of high-level E. coli contamination (>=100 colony-forming units per gram of food, cfu/g) in complementary food samples

  Food samples were collected from stored complementary foods and tested using standard culture plating. Colony counts were recorded as colony-forming units per gram (CFU/g). Samples with \>=100 CFU/g were classified as unsafe per international microbiological standards. Safety Issue: No

  Baseline; Weeks 2, 4, 6, 8, and 10

Secondary Outcomes (8)

• 7-day caregiver-reported diarrhea in children less than 23 months old

  Baseline; Weeks 2, 4, 6, 8, and 10

• Duration of food storage

  Weeks 2, 4, 6, 8, and 10

• Temperature of food storage location

  Weeks 2, 4, 6, 8, and 10

• Humidity of food storage location

  Weeks 2, 4, 6, 8, and 10

• Recall of food hygiene and meatsafe behavior-change messages

  Week 10

Study Arms (2)

Intervention Meatsafe Arm

EXPERIMENTAL

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.

Device: Meatsafe Food Storage Cabinet

Control Arm

NO INTERVENTION

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

Interventions

Meatsafe Food Storage Cabinet 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.

Intervention Meatsafe Arm

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Berkeley: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

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

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Foodborne Diseases; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The intervention is visible (physical food storage cabinet called meatsafe), and masking is not possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm RCT in which households were randomly allocated to receive either no intervention (control) or a meatsafe with food storage education (intervention).

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 12, 2026
• Study Start: August 11, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 30, 2024
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of primary findings and continuing for 3 years.
• Access Criteria: Researchers with a methodologically sound proposal may request access to de-identified IPD and supporting documents. Requests must be reviewed and approved by the principal investigators and the relevant institutional review boards (UC Berkeley CPHS and icddr,b ERC). Data will be shared under a data use agreement and transferred through secure systems.

Locations

BA (1)