- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332078
Meatsafe Food Storage and Diarrhea Prevention Trial in Urban Bangladesh
December 31, 2025 updated by: University of California, Berkeley
Evaluating the Impact of a Low-Cost Food Storage Cabinet ("Meatsafe") on Complementary Food Contamination and Diarrheal Disease in Low-Income Urban Households: A Randomized Controlled Trial in Dhaka, Bangladesh
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dhaka, Bangladesh, 1212
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: Control Arm
Households did not receive a meatsafe or safe storage education and continued their usual food preparation and storage practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of high-level E. coli contamination (>=100 colony-forming units per gram of food, cfu/g) in complementary food samples
Time Frame: Baseline; Weeks 2, 4, 6, 8, and 10
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
7-day caregiver-reported diarrhea in children less than 23 months old
Time Frame: Baseline; Weeks 2, 4, 6, 8, and 10
|
Diarrhea was defined per World Health Organization (WHO) criteria as >=3 loose stools within a 24-hour period in the past 7 days.
|
Baseline; Weeks 2, 4, 6, 8, and 10
|
|
Duration of food storage
Time Frame: Weeks 2, 4, 6, 8, and 10
|
Data collectors will record the duration that prepared complementary foods are stored using the following defined categories: <=4 hours, >4 to 8 hours and >8 hours.
|
Weeks 2, 4, 6, 8, and 10
|
|
Temperature of food storage location
Time Frame: Weeks 2, 4, 6, 8, and 10
|
Ambient temperature of the food storage area was measured in degrees Celsius using a digital thermometer.
|
Weeks 2, 4, 6, 8, and 10
|
|
Humidity of food storage location
Time Frame: Weeks 2, 4, 6, 8, and 10
|
Relative humidity of the food storage environment was recorded as a percentage (%) using a digital hygrometer.
|
Weeks 2, 4, 6, 8, and 10
|
|
Recall of food hygiene and meatsafe behavior-change messages
Time Frame: Week 10
|
Caregivers were asked to recall and describe key hygiene and storage messages from the educational handout.
|
Week 10
|
|
Meatsafe functionality
Time Frame: Weeks 2, 4, 6, 8, and 10.
|
Spot checks observation of functionality of the food storage cabinet assessed using a 3-category rating: does not close / difficult to close / closes easily.
These categories do not represent a numerical or ordinal scale.
|
Weeks 2, 4, 6, 8, and 10.
|
|
Meatsafe Cleanliness
Time Frame: Weeks 2, 4, 6, 8, and 10
|
Spot checks observation of cleanliness assessed using a 3-category rating: considerable dirt / some dirt / very clean.
These categories do not represent a numerical or ordinal scale.
|
Weeks 2, 4, 6, 8, and 10
|
|
Meatsafe screen condition
Time Frame: Weeks 2, 4, 6, 8, and 10
|
Spot checks observation of screen condition assessed using a 3-category rating: multiple holes / one hole / no holes.
These categories do not represent a numerical or ordinal scale.
|
Weeks 2, 4, 6, 8, and 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2024
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
December 31, 2025
First Posted (Estimated)
January 12, 2026
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
December 31, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
- Nutrition
- Bangladesh
- Randomized Controlled Trial (RCT)
- Child Health
- Hygiene
- Complementary Feeding
- Escherichia coli (E. coli)
- Public Health Intervention
- Food Safety
- Low- and Middle-Income Countries (LMICs)
- Complementary Foods
- Food Hygiene
- Safe Food Storage
- Meatsafe
- Urban Slum
- WASH (Water, Sanitation, and Hygiene)
- Enteric Pathogens
- Low-Cost Intervention
- Foodborne Pathogens
- Enteric Infection
- Diarrheal Disease
- Fecal-Oral Transmission
- Microbial Contamination
- Foodborne Illness
- Childhood Diarrhea Prevention
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Infections
- Chemically-Induced Disorders
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Poisoning
- Enterobacteriaceae Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Diarrhea
- Escherichia coli Infections
- Foodborne Diseases
Other Study ID Numbers
- 092000310-UCB-0310
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data (IPD), including household survey responses and microbiological food sample results, may be shared upon reasonable request.
Only de-identified data will be shared, with all personal identifiers removed, and use will be consistent with participant consent and approvals by the relevant institutional review boards: UC Berkeley Committee for Protection of Human Subjects (CPHS) and icddr,b Ethical Review Committee (ERC).
IPD Sharing Time Frame
Beginning 6 months after publication of primary findings and continuing for 3 years.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diarrhea
-
Napo Pharmaceuticals, Inc.CompletedAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
-
Aboca Spa Societa' AgricolaUnknownDiarrhea | Diarrhea, Infantile | Chronic Diarrhea | Acute Diarrhea
-
Hospital San BartolomeInstituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo...Unknown
-
South Shore HospitalWithdrawnAntibiotic Associated Diarrhea | Clostridium Difficile Associated Diarrhea
-
Lumen Bioscience, Inc.RecruitingTravelers DiarrheaAustralia
-
RedHill Biopharma LimitedNot yet recruiting
-
Water and Sanitation Program, World BankUnknown
-
SanofiCompleted
-
Cosmo Technologies LtdBausch Health Americas, Inc.CompletedTraveler's DiarrheaGuatemala, Mexico
-
Sana'a UniversityCompleted
Clinical Trials on Meatsafe Food Storage Cabinet
-
Mahidol UniversityCompleted
-
University of Southern DenmarkOdense University Hospital; University Hospital Bispebjerg and Frederiksberg; Hospital of Southern Jutland and other collaboratorsCompletedInflammatory Bowel Diseases | Ulcerative ColitisDenmark