Prevention of symptomatic enteric infection in children 6-36 months Infections and Infestations
Conditions
Interventions
After baseline data collection, clusters will be randomly allocated by an independent statistician in a 1:1 ratio to either the treatment or control arm stratified by urban/rural status (30 interventi
Nakahara et al., 2014). The intervention will also include hygienic play and dietary diversity and meal frequency promotion, which were not included in later studies, including the Gambia intervention
Nakahara et al., 2014) will be contextualised and adapted by applying the findings of a mixed-methods formative research study conducted in Mali in 2021 and developing a creative brief for a Mali crea
Sponsors
Université des Sciences, des Techniques et des Technologies de Bamako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/12/2022: Cluster inclusion criteria: 1. Permission from community leaders 2. In urban areas, clusters/communities will include predominantly poor communities to be approximately comparable to the rural clusters. The clusters in both urban and rural communities must be areas of 500 to 2,000 people (approximately 200 to 500 households). 3. These clusters are bounded by obvious environmental features including roads and rivers. 4. The clusters are also designed to have a relatively central community area. As much space as possible between cluster areas will be included to reduce the risk of contamination, either from individuals in one cluster visiting the intervention in another site, or knowledge produced by the intervention being communicated over larger areas. Participant inclusion criteria: 1. Resident within selected communities (not a visitor) 2. Has child aged 6-36 months 3. Regular child carer available for 9 hours to be observed _____ Previous inclusion criteria: Cluster inclusion criteria: 1. Permission from community leaders 2. In urban areas, clusters/communities will include predominantly poor communities to be approximately comparable to the rural clusters. The clusters in both urban and rural communities must be areas of 500 to 2,000 people (approximately 200 to 500 households). 3. These clusters are bounded by obvious environmental features including roads and rivers. 4. The clusters are also designed to have a relatively central community area. As much space as possible between cluster areas will be included to reduce the risk of contamination, either from individuals in one cluster visiting the intervention in another site, or knowledge produced by the intervention being communicated over larger areas. Participant inclusion criteria: 1. Resident within selected communities (not a visitor) 2. Has child aged 6-24 months 3. Regular child carer available for 9 hours to be observed
Exclusion criteria
Exclusion criteria: For clusters: 1. Involved in the Formative Research or the piloting of the intervention or questionnaires For participants 1. Mother or child’s main regular daytime carer not available to consent or be observed all day or the child him/herself not available the next day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Water and food safety and hygiene behaviour measured using a bespoke standard observation form (number of opportunities met (binomial)) at baseline, 4 months and 15 months 2. Food and water contamination measured through sample collection and field testing at baseline, 4 months and 15 months 3. Diarrhoea measured through observation of collected stool by field workers at baseline, 4 months and 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/02/2024, with the trialist confirming they are correct as of 12/12/2022: All data is collected by survey at baseline, 4 months and 15 months. 1. Water and food safety and hygiene behaviour (availability and use of soap in key areas for handwashing [kitchen and toilet]) 2. Diarrhoea (7-day parental report of child diarrhoea episodes [3 or more watery stools in 24 h]) 3. Uptake and fidelity of implementation of the intervention 4. Maternal knowledge 5. Maternal autonomy 6. Improved supervision and conditions of child play to reduce geophagy 7. Dietary diversity and frequency 8. Reported acute respiratory infection 9. Diarrhoea hospitalisation 10. Enteric infection 11. Growth and anthropometry 12. Cognitive development 13. Community trust, unity and social cohesion 14. Water and food safety and hygiene behaviour measured using a bespoke standard observation form (number of opportunities met [binomial]). This is for family foods and not child food which is captured as primary outcome. 15. Communal handwashing of the mother before eating herself measured through observation _____ Previous secondary outcome measures : 1. Uptake and fidelity of implementation of the intervention measured using an investigator report and survey at baseline, 4 months and 15 months 2. Maternal knowledge measured using a survey at baseline, 4 months and 15 months 3. Maternal autonomy measured using a survey questionnaire at baseline, 4 months and 15 months 4. Improved supervision and conditions of child play to reduce geophagy measured using bespoke standard observation form (number of opportunities met (binomial)) at baseline, 4 months and 15 months 5. Dietary diversity and frequency measured using a survey questionnaire (developed from DHS) at baseline, 4 months and 15 months 6. Reported acute respiratory infection measured using a survey questionnaire at baseline, 4 months and 15 months 7. Diarrhoea hospitalisation measured using a survey questi | — |
Countries
Mali
Outcome results
None listed