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

Humphrey 2019 ZIM.

Methods Cluster RCT
Participants Number: 5280 pregnant women in 211 clusters
Inclusion criteria: women were eligible if they permanently resided in a study cluster and were confirmed pregnant.
Interventions Intervention: 3 arms
  • WASH (53 clusters): standard of care messages plus information about safe disposal of faeces in a latrine, HWWS at key times, protection of infants from geophagia and ingestion of animal faeces, chlorination of drinking water (especially for infants), and hygienic preparation of complementary food. Provision of HH ventilated improved pit latrines, chlorine for water treatment, 2 handwashing facilities, soap and a plastic mat, and play space for infants.

  • IYCF (53 clusters): standard care messages plus information about the importance of nutrition for infant health, growth and development, feeding nutrient‐dense food and 20 g of LNS (Nutriset) daily from 6 to 18 months, processing foods, feeding during illness, and dietary diversity. Monthly provision of LNS sachets.

  • WASH and IYCF combined (53 clusters): standard of care messages, WASH and IYCF interventions.


Control (52 clusters): standard of care messages, which consisted of village health workers promoting exclusive breastfeeding to 6 months of age, advised on neonatal care, and promoted uptake of Ministry of Health and Child Care services, including antenatal care, immunizations, and family planning.
Outcomes Primary outcomes:
  • mean LAZ score at 18 months

  • haemoglobin concentration at 18 months


Secondary outcomes:
  • mean WAZ scores

  • WHZ scores

  • MUAC‐for‐age Z scores

  • head circumference‐for‐age Z scores

  • stunting (LAZ score < –2)

  • severely stunted (LAZ score < –3)

  • anaemic (haemoglobin concentration < 105 g/L)

  • severely anaemic (haemoglobin concentration < 70 g/L)

  • underweight (i.e. WAZ scores < –2)

  • wasted (WHZ scores < –2)

  • mean prevalence of diarrhoea (based on 7‐day maternal history of infant aged 12 months and 18 months)

  • mean prevalence of dysentery

  • mean prevalence of ARI

  • cumulative mortality up to age 18 months

  • infant environmental enteric dysfunction

  • process and intermediate outcomes

Notes Location: rural districts of Chirumanzu and Shurugwi, Zimbabwe
Length of study: 18 months' follow‐up (recruitment: November 2012 to March 2015, end of follow‐up: July 2017)
Publication status: journal
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation was random.
Allocation concealment (selection bias) Low risk Quote: "the final allocation was selected at a public randomization event attended by elected representatives of the study districts."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Masking of participants and fieldworkers was not possible because of the obvious visual differences between interventions, but investigators were blinded to treatment groups until the final analysis of each prespecified outcome."
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Masking of participants and fieldworkers was not possible because of the obvious visual differences between interventions, but investigators were blinded to treatment groups until the final analysis of each prespecified outcome."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Similar missing data 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 High risk Participants were prospectively enrolled into the study once the clusters had already been randomized to intervention groups.
Baseline imbalance Low risk Most baseline characteristics of enrolled HHs were similar across groups.
Loss of clusters Low risk < 10% (only 2 clusters lost in the IYCF group) clusters LTFU.
Incorrect analysis Low risk Accounted for clustering.