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)

Abstract

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

Coproduced, arts interventions for nurturing care (0–5 years) in low-income and middle-income countries (LMICs): a realist review

“…MaaCiwara is an ongoing study with collaborations between institutions in Mali and the UK examining the impact of an intervention in Mali for nurturing care, with significant arts-based elements. 36 Our preliminary objectives for this review were to identify examples of arts-based interventions coproduced between communities affected by poor child health, nutrition, and development outcomes and those involved in the public health/health promotion sector in LMICs and/or research organisations; to develop an understanding of the theoretical frameworks that inform these interventions or can help explain their effects, and to understand the mechanisms that contribute to success for these interventions. As the review progressed, we introduced a second research question focused on the long-term potential of these sorts of interventions to have an impact within the original context and in other similar ones.…”