评估马里社区层面补充食品安全与卫生及营养干预措施的整群随机试验的统计分析计划：MaaCiwara研究

Statistical analysis plan for cluster randomised trial to evaluate a community-level complementary food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study.

作者信息

Quinn Laura, Martin James, Asamane Evans, Manaseki-Holland Semira, Lilford Richard J, Traore Lacina, Thompson Jacqueline, Watson Samuel I, Hemming Karla

机构信息

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

出版信息

Trials. 2024 Jul 16;25(1):483. doi: 10.1186/s13063-024-08328-x.

DOI:10.1186/s13063-024-08328-x

PMID:39014428

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11253307/

Abstract

BACKGROUND

Diarrheal disease is a significant cause of morbidity and mortality in under-fives in many low- and middle-income countries. Changes in food safety, hygiene practices, and nutrition around the weaning period may reduce the risk of disease and improve infant development. The MaaCiwara study aims to evaluate the effectiveness of a community-based educational intervention designed to improve food safety and hygiene behaviours, as well as child nutrition. This update article describes the statistical analysis plan for the MaaCiwara study in detail.

METHODS AND DESIGN

The MaaCiwara study is a parallel group, two-arm, superiority cluster randomised controlled trial with baseline measures, involving 120 clusters of rural and urban communities. These clusters are randomised to either receive the community-based behaviour change intervention or to the control group. The study participants will be mother-child pairs, with children aged between 6 and 36 months. Data collection involves a day of observation and interviews with each participating mother-child pair, conducted at baseline, 4 months, and 15 months post-intervention. The primary analysis aims to estimate the effectiveness of the intervention on changes to complementary food safety and preparation behaviours, food and water contamination, and diarrhoea. The primary outcomes will be analysed generalised linear mixed models, at individual level, accounting for clusters and rural/urban status to estimate the difference in outcomes between the intervention and control groups. Secondary outcomes include maternal autonomy, enteric infection, nutrition, child anthropometry, and development scores. In addition, structural equation analysis will be conducted to examine the causal relationships between the different outcomes.

TRIAL REGISTRATION

International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN14390796 . Registered on 13 December 2021.

摘要

背景

腹泻病是许多低收入和中等收入国家五岁以下儿童发病和死亡的重要原因。断奶期前后食品安全、卫生习惯和营养状况的改变可能会降低疾病风险并改善婴儿发育。MaaCiwara研究旨在评估一项以社区为基础的教育干预措施的有效性，该干预措施旨在改善食品安全和卫生行为以及儿童营养状况。这篇更新文章详细描述了MaaCiwara研究的统计分析计划。

方法与设计

MaaCiwara研究是一项平行组、双臂、优效性整群随机对照试验，有基线测量，涉及120个农村和城市社区整群。这些整群被随机分为接受以社区为基础的行为改变干预组或对照组。研究参与者将是母婴对，儿童年龄在6至36个月之间。数据收集包括在基线、干预后4个月和15个月对每对参与的母婴进行一天的观察和访谈。主要分析旨在评估干预措施对辅食食品安全和制备行为、食物和水污染以及腹泻变化的有效性。主要结局将在个体层面使用广义线性混合模型进行分析，考虑整群和农村/城市状况，以估计干预组和对照组之间结局的差异。次要结局包括母亲自主权、肠道感染、营养、儿童人体测量和发育得分。此外，将进行结构方程分析以检验不同结局之间的因果关系。