دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Quinn L; Institute of Applied Health Research, University of Birmingham, Birmingham, UK. l.quinn@bham.ac.uk., Martin J; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Asamane E; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Manaseki-Holland S; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Lilford RJ; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Traore L; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Thompson J; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Watson SI; Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Hemming K; Institute of Applied Health Research, University of Birmingham, Birmingham, UK. |
| المصدر: | Trials [Trials] 2024 Jul 16; Vol. 25 (1), pp. 483. Date of Electronic Publication: 2024 Jul 16. |
| نوع المنشور: | Journal Article; Clinical Trial Protocol |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BioMed Central, 2006- |
| مواضيع طبية MeSH: | Hygiene* , Food Safety* , Randomized Controlled Trials as Topic*, Humans ; Infant ; Mali ; Child, Preschool ; Female ; Infant Nutritional Physiological Phenomena ; Nutritional Status ; Data Interpretation, Statistical ; Male ; Diarrhea/prevention & control ; Diarrhea/epidemiology |
| مستخلص: | 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. (© 2024. The Author(s).) |
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| معلومات مُعتمدة: | MR/T030011/1 Medical Research Council (MRC), UK Research and Innovation (UKRI) Global Challenges Research Fund (GCRF) |
| فهرسة مساهمة: | Keywords: Cluster randomised controlled trial; Food safety and hygiene; Statistical analysis plan |
| تواريخ الأحداث: | Date Created: 20240716 Date Completed: 20240717 Latest Revision: 20240719 |
| رمز التحديث: | 20240719 |
| مُعرف محوري في PubMed: | PMC11253307 |
| DOI: | 10.1186/s13063-024-08328-x |
| PMID: | 39014428 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1745-6215 |
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| DOI: | 10.1186/s13063-024-08328-x |