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

BackgroundSymptomatic 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, and no studies in low income urban settings where risks are plausibly very high. 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.MethodsThis 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 targeted 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, including when reheating or reserving; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean.ResultsThe 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.ConclusionTo 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 Safe Start trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children.Trial registrationThe trial was registered at clinicaltrial.gov on March 16th 2018 before enrolment of any participants (https://clinicaltrials.gov/ct2/show/NCT03468114).

Microbiological Contamination in Different Food Service Units Associated with Food Handling

“…Our results also emphasized that Schools/Kindergartens have patterns of good hygiene practices associated with utensils, supported by the absence of E. coli and the highest proportion of samples with mesophilic microorganisms below 100 CFUs. A recent study reported that appropriate food hygiene interventions among child caregivers of weaning infants, focused on safe hand hygiene, safe food preparation and storage, as well as safe feeding, can reduce foodborne exposure to enteric pathogens [38].…”

Impact of a demand-side integrated WASH and nutrition community-based care group intervention on behavioural change: a randomised controlled trial in western Kenya

“…Our intervention resulted in substantial improvements in hygienic food preparation areas (outcome 1) and safe storage of food (outcome 2). Though food is one of the most critical pathways for children to be exposed to faecal pathogens, 48 food hygiene interventions are underemphasised in WASH and nutrition programming, and few studies have measured the impact of any 49 Food hygiene presented a contextual challenge related to the larger sociocultural realities of caretakers. 50 In addition, different high-risk foods require different food hygiene strategies; for example, if milk is the primary vector for food-related pathogens, 51 it would require a different type of hazard mitigation than porridge.…”

Influence of milk product safety and household food hygiene on bacterial contamination of infant food in peri-urban Kenya

“…These densely populated wards are characterized by lack of improved sanitation facilities, use of county-provided water points, poor housing, and high rates of poverty. The Safe Start study evaluates the effect of a food hygiene intervention targeting early childhood exposure to enteric pathogens through contaminated food (ClinicalTrials.gov ID: NCT03468114) 15 . The protocol includes a midline visit at 8 months of age to observe the caregiver prepare food and feed the child, and to take a food sample for microbial testing.…”

“…Formative research on caregiver experiences and infant food safety 7 16 , and the challenges for Community Health Volunteers (CHVs) in delivery of health care information 17 informed study design. The design of the Safe Start intervention was optimized through an interactive pilot study 18 and CHVs were involved in the implementation of the study 15 . Community knowledge dissemination meetings were convened after the study to discuss results with the community.…”