• Buba Manjang, Karla Hemming, Chris Bradley, Jeroen Ensink, James T Martin, Jama Sowe, Abdou Jarju, Sandy Cairncross, and Semira Manaseki-Holland.
• Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
• BMJ Open. 2018 Aug 5; 8 (8): e017573.

ObjectiveContamination of weaning food leads to diarrhoea in children under 5 years. Public health interventions to improve practices in low-income and middle-income countries are rare and often not evaluated using a randomised method. We describe an intervention implementation and provide baseline data for such a trial.DesignClustered randomised controlled trial.SettingRural Gambia.Participants15 villages/clusters each with 20 randomly selected mothers with children aged 6-24 months per arm.InterventionTo develop the public health intervention, we used: (A) formative research findings to determine theoretically based critical control point corrective measures and motivational drives for behaviour change of mothers; (B) lessons from a community-based weaning food hygiene programme in Nepal and a handwashing intervention programme in India; and (C) culturally based performing arts, competitions and environmental clues. Four intensive intervention days per village involved the existing health systems and village/cultural structures that enabled per-protocol implementation and engagement of whole villager communities.ResultsBaseline village and mother's characteristics were balanced between the arms after randomisation. Most villages were farming villages accessing health centres within 10 miles, with no schools but numerous village committees and representing all Gambia's three main ethnic groups. Mothers were mainly illiterate (60%) and farmers (92%); 24% and 10% of children under 5 years were reported to have diarrhoea and respiratory symptoms, respectively, in the last 7 days (dry season). Intervention process engaged whole village members and provided lessons for future implementation; culturally adapted performing arts were an important element.ConclusionThis research has potential as a new low-cost and broadly available public health programme to reduce infection through weaning food. The theory-based intervention was widely consulted in the Gambia and with experts and was well accepted by the communities. Baseline analysis provides socioeconomic data and confirmation of Unicefs Multiple Indicator Cluster Survey (MICS) data on the prevalence of diarrhoea and respiratory symptoms in the dry season in the poorest region of Gambia.Trial Registration NumberPACTR201410000859336; Pre-results.© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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