Evaluation of a community-level complementary-food safety and hygiene, and nutrition intervention - the MaaCiwara study

Not Applicable

• Conditions: Prevention of symptomatic enteric infection in children 6-36 months; Infections and Infestations

• Registration Number: ISRCTN14390796
• Lead Sponsor: niversité des Sciences, des Techniques et des Technologies de Bamako

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36717923/ (added 02/02/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-13
• Last Update Posted: 29 July 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3240

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

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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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Food and water contamination measured through sample collection and field testing at baseline, 4 months and 15 months<br>3. Diarrhoea measured through observation of collected stool by field workers at baseline, 4 months and 15 months