Effects on childhood infections of promoting safe and hygienic complementary-food handling practices through a community based programme: A cluster randomised controlled trial in a rural area of The Gambia

Semira Manaseki-Holland, Buba Manjang, Karla Hemming, James Martin, Chris Bradley, Louise Jackson, Makie Taal, Om Prasad Gautam, Francesca Crowe, Bakary Sanneh, Jeroen Ensink, Tim Stokes, Sandy Cairncross

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BACKGROUND: The Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rates.

METHODS AND FINDINGS: A public health intervention using critical control points and motivational drivers, delivered February-April 2015 in The Gambia, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up in September-October 2015 and October-December 2017, respectively. After consent for trial participation and baseline data were collected, 30 villages (clusters) were randomly assigned to intervention or control, stratified by population size and geography. The intervention included a community-wide campaign on days 1, 2, 17, and 25, a reminder visit at 5 months, plus informal community-volunteer home visits. It promoted 5 key complementary-food and 1 key drinking-water safety and hygiene behaviours through performing arts, public meetings, and certifications delivered by a team from local health and village structures to all villagers who attended the activities, to which mothers of 6- to 24-month-old children were specifically invited. Control villages received a 1-day campaign on domestic-garden water use. The background characteristics of mother and clusters (villages) were balanced between the trial arms. Outcomes were measured at 6 and 32 months in a random sample of 21-26 mothers per cluster. There were no intervention or research team visits to villages between 6 and 32 months. The primary outcome was a composite outcome of the number of times key complementary-food behaviours were observed as a proportion of the number of opportunities to perform the behaviours during the observation period at 6 months. Secondary outcomes included the rate of each recommended behaviour; microbiological growth from complementary food and drinking water (6 months only); and reported acute respiratory infections, diarrhoea, and diarrhoea hospitalisation. Analysis was by intention-to-treat analysis adjusted by clustering. (Registration: PACTR201410000859336). We found that 394/571 (69%) of mothers with complementary-feeding children in the intervention villages were actively involved in the campaign. No villages withdrew, and there were no changes in the implementation of the intervention. The intervention improved behaviour adoption significantly. For the primary outcome, the rate was 662/4,351(incidence rate [IR] = 0.15) in control villages versus 2,861/4,378 (IR = 0.65) in intervention villages (adjusted incidence rate ratio [aIRR] = 4.44, 95% CI 3.62-5.44, p < 0.001), and at 32 months the aIRR was 1.17 (95% CI 1.07-1.29, p = 0.001). Secondary health outcomes also improved with the intervention: (1) mother-reported diarrhoea at 6 months, with adjusted relative risk (aRR) = 0.39 (95% CI 0.32-0.48, p < 0.001), and at 32 months, with aRR = 0.68 (95% CI 0.48-0.96, p = 0.027); (2) mother-reported diarrhoea hospitalisation at 6 months, with aRR = 0.35 (95% CI 0.19-0.66, p = 0.001), and at 32 months, with aRR = 0.38 (95% CI 0.18-0.80, p = 0.011); and (3) mother-reported acute respiratory tract infections at 6 months, with aRR = 0.67 (95% CI 0.53-0.86, p = 0.001), though at 32 months improvement was not significant (p = 0.200). No adverse events were reported. The main limitations were that only medium to small rural villages were involved. Obtaining laboratory cultures from food at 32 months was not possible, and no stool microorganisms were investigated.

CONCLUSIONS: We found that low-cost and culturally embedded behaviour change interventions were acceptable to communities and led to short- and long-term improvements in complementary-food safety and hygiene practices, and reported diarrhoea and acute respiratory tract infections.

TRIAL REGISTRATION: The trial was registered on the 17th October 2014 with the Pan African Clinical Trial Registry in South Africa with number (PACTR201410000859336) and 32-month follow-up as an amendment to the trial.

Original languageEnglish
Article numbere1003260
JournalPLoS Medicine
Issue number1
Publication statusPublished - 11 Jan 2021

Bibliographical note

Funding Information:
I. The first phase that included the first follow-up at 6m was funded by: 1. The Islamic Development Bank PhD scholarship for BM, and some of the fieldwork, Co-PI and supervisor for the grant application was SMH. Website: https://www. isdb.org/scholarships/phd-and-post-doctoralresearch-programme; grant number 600014388 2. The UK Department for International Development (DFID) through the SHARE Consortium, provided funds for fieldwork; PIs for application were BM & SMH; co-applicants were SC, JE, KH, CB. Website: https://www.shareresearch.org/; grant number ITDCHA23-MR36 3. The UNICEF Gambia provided small WASH project grant for field work only in 2015; PIs for application were BM & SMH; co-applicants were SC, JE, KH, CB. Website: https:// www.unicef.org/infobycountry/gambia_contact. html; no grant number available as this was a small in country grant of $9000 4. The health facilities data collection was funded by the personal resources of the masters student, MT. II. The 32-month follow-up was funded by Medical Research Council?s Confidence in Concept funds and Institute of Global Innovation of the University of Birmingham. This funded the field work and analysis. PIs for application were BM & SMH; co-applicants were SC, JE, KH, CB. Website: https:// intranet.birmingham.ac.uk/finance/RSS/researchdevelopment/internal-funding.aspx; grant number RRAK20175 Substantial funding in kind was also made by the Government of Gambia (Ministry of Health Regional Office and Bansang Hospital) during the 6 and 32 month follow-up. All other work were performed by core funded staff of UOB without external funding. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© 2021 Manaseki-Holland et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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