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. 2019 Sep 24;2019(9):CD011055. doi: 10.1002/14651858.CD011055.pub2

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.
Interventions Intervention : 6 intervention arms
  • Water quality (77 clusters, each consisting of 1–3 neighbouring villages to have ≥ 6 pregnant women per cluster): chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water. Behaviour change messaging to treat drinking water for all children aged < 36 months.

  • Sanitation (77 clusters): provision of free child potties, sani‐scoop to remove faeces from HH environments, and latrine upgrades or construction of latrine if did not own 1. For promotion, local promoters visited study compounds to deliver behaviour change messages on the use of latrines for defecation and the removal of human and animal faeces from the compound.

  • Hand washing (77 clusters): handwashing stations, soapy water bottles, detergent soap to supply soapy water. Behaviour change messages focused on HWWS at critical times around food preparation, defecation, and contact with faeces.

  • Combined WASH (76 clusters): water quality, sanitation, and handwashing components.

  • Nutrition (78 clusters): LNS given twice daily for children 6–24 months. The key recommendations for nutrition were: dietary diversity during pregnancy and lactation, early initiation of breastfeeding, exclusive breastfeeding until 6 months, introduction of appropriate and diverse complementary foods at 6 months, and continued breastfeeding through 24 months.

  • Nutrition + combined WASH (79 clusters).


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.
Outcomes Primary outcomes:
  • LAZ scores (measured 24 months after intervention)

  • diarrhoea prevalence (defined as ≥ 3 loose or watery stools in 24 hours or ≥ 1 stools with blood in 24 hours. Diarrhoea was measured in interviews using caregiver‐reported symptoms with 7‐day recall, measured 12 and 24 months after intervention)


Secondary outcomes:
  • LAZ scores

  • weight for length Z score

  • WAZ score

  • head circumference‐for‐age Z score

  • prevalence of moderate stunting (LAZ score < –2)

  • severe stunting (LAZ score < –3)

  • underweight (WAZ score < –2)

  • wasting (WAZ score < –2)

  • enteropathy biomarkers (measured 12 and 24 months after intervention)

  • Ages and Stages Questionnaire Child Development Scores (measured 24 months after intervention)


Tertiary outcome:
  • all‐cause mortality among index children

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
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.