Evidence map›Paper›PMID 36717923›Full record

ArticleTrials2023

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).

Evans A Asamane, Laura Quinn, Samuel I Watson, Richard J Lilford, Karla Hemming, Cheick Sidibe, Ryan T Rego, Sami Bensassi, Youssouf Diarra, Samba Diop and 13 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 8 institutions in 6 countries.

Evans A AsamaneInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.ORCID http://orcid.org/0000-0002-6430-7787
Laura QuinnInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Samuel I WatsonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Richard J LilfordInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Karla HemmingInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Cheick SidibeUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Ryan T RegoCenter for Global Health Equity, University of Michigan, Ann Arbor, USA.
Sami BensassiBirmingham Business School, University of Birmingham, Birmingham, UK.
Youssouf DiarraUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Samba DiopUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Om Prasad GautamWater Aid, London, UK.
Mohammad Sirajul IslamInternational Center for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Louise JacksonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Kate JollyInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Kassoum KayentaoUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Ousmane KoitaUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Buba ManjangMinistry of Health, Banjul, Gambia.
Susan TebbsInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Nicola GaleSchool of Social Policy, Health Services Management Centre, University of Birmingham, Birmingham, UK.
Paula GriffithsSchool of Sport, Exercise and Health Sciences Loughborough University, London, UK.
Sandy CairncrossFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Ousmane ToureUniversity of Science, Techniques and Technology Bamako, Bamako, Mali.
Semira Manaseki-HollandInstitute of Applied Health Research, University of Birmingham, Birmingham, UK. S.manasekiholland@bham.ac.uk.
University of Birmingham · GBUniversité des Sciences, des Techniques et des Technologies de Bamako · MLInternational Centre for Diarrhoeal Disease Research · BDLondon School of Hygiene & Tropical Medicine · GBLoughborough University · GBMinistry of Health and Social Welfare · GMUniversity of Michigan · USWaterAid · GB

Funding

Medical Research Council MR/T030011/1Medical Research Council MR/W020688/1
6 · The paper itself

Abstract

backgroundDiarrhoeal 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.

methodsWe 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.

conclusionsThe 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 registrationISRCTN14390796. Registration date December 13, 2021.

Indexed as

Food SafetyMothersDiarrheaEquivalence Trials as TopicFemaleHumansHygieneInfantMaliRandomized Controlled Trials as TopicBehaviour changeCluster randomised controlled trialDiarrhoeal diseaseHygiene

Identifiers

PMID36717923
PMCPMC9885702
OpenAlexW4318475752

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.