International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212, Bangladesh
NCT Number: NCT07332078
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.
Looking for future studies?
Notify Me6 month–24 month
All sexes
Interventional
Not applicable
Dhaka, 1212, Bangladesh
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
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.
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.
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.
Time frame: Week 10
Caregivers were asked to recall and describe key hygiene and storage messages from the educational handout.
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.
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.
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.
University of California, Berkeley
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03404674
Bacterial Infections, Bacterial Infections and Mycoses
Silver Spring, Maryland, United States
View Trial DetailsNCT00742469
Bacterial Infections, Bacterial Infections and Mycoses
Guadalajara, Jalisco, Mexico
View Trial DetailsNCT00328380
Bacterial Infections, Bacterial Infections and Mycoses
South Miami, Florida, United States
View Trial DetailsNCT03596827
Bacterial Infections, Bacterial Infections and Mycoses
Ede, Gelderland, Netherlands
View Trial Details