Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
University of Science, Techniques and Technology Bamako, Bamako, Mali.
Trials. 2023 Jan 30;24(1):68. doi: 10.1186/s13063-022-06984-5.
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.
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.
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.
ISRCTN14390796. Registration date December 13, 2021.
在许多中低收入国家，腹泻病仍然是导致五岁以下儿童发病和死亡的一个重要原因。在断奶期间，食品安全实践和喂养方式的改变，以及营养状况的改善，可能会显著降低疾病风险，促进婴儿发育。我们描述了一项集群随机试验的方案，以评估一项多方面基于社区的教育干预措施的有效性，该措施旨在改善食品安全和卫生行为，增强儿童营养。
我们描述了一项混合方法、平行组、两臂、优效性集群随机对照试验，具有基线测量。将以相等数量招募 120 个包含小型城市和农村社区的集群，并以 1:1 的比例随机分配到治疗组或对照组。社区干预将围绕一个理想母亲的概念展开，在宣传日期间让所有社区成员参与戏剧艺术和宣誓活动，并进行后续家访。参与者将是母婴对子（每个集群期间 27 对），儿童年龄为 6 至 36 个月。数据收集将包括对每个参与的母婴对子进行为期一天的观察和访谈，并在基线以及干预后 4 个月和 15 个月进行。主要分析将估计干预对补充食品安全性和制备行为、食物和水污染以及腹泻变化的有效性。次要结果包括产妇自主权、肠道感染、营养、儿童人体测量学和发育评分。还将进行额外的结构方程分析，以检验不同结果之间的因果关系。将进行定性和健康经济分析，包括过程评估。
该试验将提供关于旨在减轻五岁以下儿童腹泻病负担的基于社区的行为改变干预措施的有效性的证据，以及该有效性如何因不同背景而异。
ISRCTN82601234。注册日期为 2021 年 12 月 13 日。
