The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

Abstract

Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, especially in low-income urban settings. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targets four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria ( Enterococcus ) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the extension system can improve the health of young children.

Determinants of food preparation and hygiene practices among caregivers of children under two in Western Kenya: a formative research study

“…Changes to physical and social opportunity have been addressed in interventions by the WASH Benefits study and the Safe Start trial. In these intervention trials, caregivers received handwashing stations, soap, food storage containers; and education and motivational messaging thus demonstrating improved knowledge and practice on proper food hygiene practices [58,59].…”

Environmental and behavioral exposure pathways associated with diarrhea and enteric pathogen detection in twenty-six week old urban Kenyan infants: a cross-sectional study

“…This cross-sectional study uses baseline data collected from six month old infants and their caregivers at the point of enrollment into Safe Start cluster-randomized controlled trial of an infant food hygiene behavior change intervention in Kisumu, Kenya (Clinical Trials identifier: NCT03468114). The formative work and trial protocol, including the estimation of sample size for evaluating trial impact, are described elsewhere [25][26][27][28][29]…”

“…handwashing, water treatment) conditions in modifying pathogen exposure risks from human and animal feces sources for 6 month old infants in Kisumu, Kenya. This study utilizes enrollment data for infants in the Safe Start Trial 25 , a cluster-randomized trial of an infant food hygiene behavior change intervention. To achieve this goal, we estimated associations between water, animal, sanitation, hygiene, food, and flooring conditions with caregiver report of 7-day diarrhea prevalence in infants, and with sum count of pathogen types detected in infant stool as determined by molecular diagnostic assays.…”