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).
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).
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腹泻病仍然是许多中低收入国家五岁以下儿童发病和死亡的一个重要原因。在断奶期间改变食品安全做法和喂养方法，以及改善营养，可能会显着降低疾病风险并改善婴儿的发育。我们描述了一个群集随机试验的协议，以评估多方面的社区为基础的教育干预，旨在改善食品安全和卫生行为，提高儿童营养的有效性。我们描述了一个混合方法，平行组，双臂，优势集群随机对照试验与基线措施。将招募相同数量的120个由小型城市和农村社区组成的群组，并以1：1的比例随机分配至治疗组或对照组。社区干预活动将围绕理想母亲概念展开，在活动日期间，所有社区成员都将参与，并进行戏剧艺术和宣誓，以及后续家访。参与者将是6至36个月大的母子二人组（每群27人）。数据收集将包括一天的观察和采访每对参与的母亲-儿童，并将在基线和干预后4个月和15个月进行。初步分析将评估干预措施在改变补充食品安全和准备行为、食品和水污染以及腹泻方面的有效性。次要结局包括母亲自主性、肠道感染、营养、儿童人体测量和发育评分。将进行额外的结构方程分析，以检查不同结局之间的因果关系。将进行定性和卫生经济分析，包括过程评价。该试验将提供证据，证明旨在减少五岁以下儿童肠道疾病负担的基于社区的行为改变干预措施的有效性，以及不同情况下的有效性如何变化。ISRCTN14390796。注册日期2021年12月13日在线版本包含补充材料，可在10.1186/s13063 - 022 - 06984 - 5获得。
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 The online version contains supplementary material available at 10.1186/s13063-022-06984-5.
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影响因子：
15.8
作者：
Manaseki-Holland S;Manjang B;Hemming K;Martin JT;Bradley C;Jackson L;Taal M;Gautam OP;Crowe F;Sanneh B;Ensink J;Stokes T;Cairncross S
通讯作者：
Cairncross S
DOI：
10.1016/j.socscimed.2014.08.019
发表时间：
2015-01
期刊：
Social science & medicine (1982)
影响因子：
--
作者：
Perkins JM;Subramanian SV;Christakis NA
通讯作者：
Christakis NA
影响因子：
2.3
作者：
Eldridge, Sandra M.;Costelloe, Ceire E.;Kerry, Sally M.
通讯作者：
Kerry, Sally M.
影响因子：
7.7
作者：
Hemming, Karla;Kasza, Jessica;Taljaard, Monica
通讯作者：
Taljaard, Monica
影响因子：
3.3
作者：
Gautam, Om Prasad;Schmidt, Wolf-Peter;Curtis, Valerie
通讯作者：
Curtis, Valerie