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

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. Author summary Why was this study done? Children aged 0-2 years are fed complementary foods and have the highest rates of diarrhoea and food-borne illnesses. Most hygiene or child nutrition programmes do not directly address complementary-food safety and hygiene. We performed a large cluster randomised controlled trial (RCT) of a community-level complementary-food safety and hygiene intervention in which medium- and long-term health outcomes were measured. What did the researchers do and find? We used a cluster RCT study to test a novel community-level campaign-like intervention in 15 intervention and 15 control villages in rural Gambia and evaluated outcomes at 6 and 32 months post-intervention. Target behaviours were identified through systematic assessment of motivational drivers for behaviour change and critical control points (CCPs) for contamination in complementary-food preparation and handling practices identified through a hazard analysis assessment. The intervention was implemented at the community level and focussed on mothers of young children; it was delivered by a combination of performing arts, public meetings, household visits, commitment ceremonies, and certifications of mothers and communities. Sixty-nine percent of mothers with complementary-feeding-age children were actively involved in the campaign. At 6 months post-intervention, adoption of behaviours was high; child's reported diarrhoea, hospital admission for diarrhoea, and respiratory disease were reduced by 60%, 60%, and 30%, respectively. At 32 months post-intervention, mothers in control villages had adopted some of the behaviours promoted by the intervention (intervention 'cross-contamination'), but practice of the behaviours in the intervention villages remained significantly higher, with a 30% reduction in reported diarrhoea and a 40% reduction in hospital admissions for diarrhoea. Clinic data collected by another research team confirmed reduced diarrhoea visits. These outcomes were achieved without further programmatic input after 5 months. Mothers without babies at the time of the programme were subsequently engaged by community members and adopted the behaviours. The intervention adds further value as it was delivered by a team from the public health and village structures, and was low intensity and low cost. What do these findings mean? We demonstrate that these low-cost, culturally embedded interventions are acceptable, adopted, and sustained at the community level, with high levels of behaviour change and reported reduction in diarrhoea and acute respiratory infection outcomes in the short term, and significant long-term effects. Interventions of this form could make an invaluable contribution to diarrhoea prevention; although our findings are limited to small rural villages, these are nonetheless common in low- and middle-income countries. Our conclusions need to be tested in urban and peri-urban settings. To date, insufficient attention has been devoted to food safety and food hygiene practices aimed at preparing, handling, and feeding complementary food. There have also been insufficient assessments of programmes with cultural performing arts that can engage whole communities to support mothers with behaviour change.

Automated summary

A community-based intervention in The Gambia successfully increased adoption of key complementary-food safety hygiene behaviors through a public health campaign and volunteer home visits, leading to significant improvements in health outcomes such as reported reduction in diarrhoea and acute respiratory tract infections in both short-term and long-term evaluations.