Null 2018 KEN.
Methods | Cluster RCT | |
Participants | Number: 6494 children with diarrhoea data at year 1 or 2 in all arms. Children who were in utero or aged < 3 years at enrolment Inclusion criteria: children of enrolled pregnant women (index children) were eligible for inclusion if their mother was planning to live in the study village for the next 2 years, regardless of where she gave birth. Only 1 pregnant woman (in the first 2 trimesters of her pregnancy) was enrolled per compound, but if she gave birth to twins, both children were enrolled. Children aged < 3 years at enrolment and lived in the compound were included in diarrhoea measurements. |
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Interventions | Intervention : 6 intervention arms
Control (158 clusters): no intervention, monthly visits by community‐based health promoter to measure the child's MUAC. Passive control (80 clusters): no activity apart from data collection. |
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Outcomes | Primary outcomes:
Secondary outcomes:
Tertiary outcome:
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Notes | Location: rural villages in Bungoma, Kakamega, and Vihiga counties in Kenya's western region Length of study: 42 months (recruitment: 27 November 2012 to 21 May 2014 with 2 years' follow‐up) Publication status: journal |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Clusters were randomly allocated to treatment using a random number generator with reproducible seed at the University of California, Berkeley." |
Allocation concealment (selection bias) | Low risk | Quote: "Clusters were randomly allocated to treatment using a random number generator with reproducible seed at the University of California, Berkeley." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Blinding of participants was not possible. Participants were informed of their treatment assignment after baseline data collection and might have known the treatment assignment of nearby villages." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The health promoters and staff who delivered the interventions were not involved in data collection, but the data collection team could have inferred treatment status if they saw intervention materials in study communities." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up fairly balanced across groups. |
Selective reporting (reporting bias) | Unclear risk | Reported on primary outcomes but future publications will cover additional prespecified outcomes. |
Other bias | Unclear risk | — |
Similarity of baseline outcome measurements | Unclear risk | — |
Similarity of baseline characteristics | Unclear risk | — |
Adequate allocation of intervention concealment during the study | Unclear risk | — |
Adequate protection against contamination | Unclear risk | — |
Confounders adequately adjusted for in analysis/design | Unclear risk | — |
Recruitment bias | Low risk | Participants were enrolled prior to knowing allocation of intervention. |
Baseline imbalance | Low risk | Baseline characteristics of enrolled HHs were similar across groups. |
Loss of clusters | Low risk | No reported loss of cluster. |
Incorrect analysis | Low risk | Accounted for clustering in analysis. |