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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.
Original language | English |
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Article number | 68 |
Number of pages | 17 |
Journal | Trials |
Volume | 24 |
Issue number | 1 |
DOIs | |
Publication status | Published - 30 Jan 2023 |
Bibliographical note
© 2023. The Author(s).Keywords
- Infant
- Female
- Humans
- Mali
- Mothers
- Food Safety
- Hygiene
- Diarrhea/prevention & control
- Randomized Controlled Trials as Topic
- Behaviour change
- Cluster randomised controlled trial
- Diarrhoeal disease
- Study Protocol
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Dive into the research topics of '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)'. Together they form a unique fingerprint.Projects
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Effect of urban vs rural context on effectiveness of a community intervention to prevent diarrhoea and stunting in young children in Mali
Jackson, L. (Co-Investigator), Jolly, K. (Co-Investigator), Gale, N. (Co-Investigator), Bensassi, S. (Co-Investigator), Hemming, K. (Researcher), Tebbs, S. (Co-Investigator), Manaseki-Holland, S. (Principal Investigator), Asamane, E. (Co-Investigator), Watson, S. (Researcher), Weber, K. (Researcher), Lilford, R. (Researcher), Quinn, L. (Researcher), Martin, J. (Researcher) & Adams, R. (Researcher)
1/01/21 → 31/03/25
Project: Research Councils