Protocol for a parallel group, two-arm, superiority cluster randomised trial to evaluate a community-level complementary-food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study (version 1.3; 10 November 2022).

BACKGROUND: Diarrhoeal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. We describe a protocol for a cluster randomised trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition. METHODS: We describe a mixed-methods, parallel group, two-arm, superiority cluster randomised controlled trial with baseline measures. One hundred twenty clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. The community intervention will be focussed around an ideal mother concept involving all community members during campaign days with dramatic arts and pledging, and follow-up home visits. Participants will be mother-child dyads (27 per cluster period) with children aged 6 to 36 months. Data collection will comprise a day of observation and interviews with each participating mother-child pair and will take place at baseline and 4 and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary-food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutrition, child anthropometry, and development scores. A additional structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Qualitative and health economic analyses including process evaluation will be done. CONCLUSIONS: The trial will provide evidence on the effectiveness of community-based behavioural change interventions designed to reduce the burden of diarrhoeal disease in the under-fives and how effectiveness varies across different contexts. TRIAL REGISTRATION: ISRCTN14390796. Registration date December 13, 2021.

Cost-effectiveness of a weaning food safety and hygiene programme in rural Gambia.

OBJECTIVE: The main objective of the economic evaluation was to determine the cost-effectiveness of a weaning food safety and hygiene programme in reducing rates of diarrhoea compared with the control in rural Gambia. METHODS: The public health intervention, using critical control points and motivational drivers, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up. An economic evaluation was undertaken alongside the RCT with data collected prospectively from a societal perspective. Decision-analytic modelling was used to explore cost-effectiveness over a longer time period (4 years). RESULTS: Direct out-of-pocket healthcare expenditure for households due to diarrhoea was large. The intervention significantly reduced reported childhood diarrhoeal episodes after 6 months (incident risk ratio = 0.40, 95% CI 0.33, 0.49) and 2 years after the intervention (incident risk ratio = 0.68, 95% CI 0.46, 1.02). The within-trial analysis found that the intervention led to total savings of 8064 dalasi 6 months after the intervention and 4224 dalasi 2 years after the intervention. Based on the model results, if the intervention is successful in maintaining the reduction in the risk of diarrhoea, the ICER is US$ 814 per DALY avoided over 4 years. This is cost-effective. CONCLUSIONS: This study suggests that there are substantial household costs associated with diarrhoeal episodes in children. The within-trial analysis and model results suggest that the community-based approach to improving weaning food hygiene and safety is likely to be cost-effective compared with control.