Sinharoy 2017 RWA.
Methods | Cluster RCT | |
Participants | Number: 10,793 children aged < 5 years at end of study (7934 HHs) (after 18.6% of children < 5 years LTFU) Inclusion criteria: all HHs with a child aged < 5 years in the study area |
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Interventions | Interventions, 2 arms testing 2 different versions of the CBEHPP, which used the CHC approach to promote healthy practices.
Both the lite and classic intervention included messages on child sanitation under the topic of sanitation (zero open defecation). The participants were mainly recommended the following:
Control (50 villages), baseline: 2948 HHs (4523 children aged < 5 years); end of study: 2723 HHs (3782 children aged < 5 years): no intervention |
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Outcomes | Diarrhoea (7‐day recall) Height‐for‐age or LAZ score WHZ or weight‐for‐length Z score Colony‐forming units of thermotolerant (faecal) coliforms per 100 mL water Intermediary outcomes:
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Notes | Location: 150 villages in Rusizi district, Western Rwanda Length of study: 32 months (May 2013 to December 2015) Publication status: published |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We assessed villages for eligibility then randomly selected 150 [villages] for the study using a simple random sampling routine in STATA. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver‐reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n = 50), eight community health club sessions (Lite intervention; n = 50), or 20 community health club sessions (Classic intervention; n = 50)." |
Allocation concealment (selection bias) | Low risk | Quote: "used Stata to randomly order the villages and divide them into three groups with approximately the same number of villages in each group." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding and some outcomes were self‐reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No difference in attrition between intervention groups." |
Selective reporting (reporting bias) | Low risk | Report on outcomes specified in methods apart from clinical data for diarrhoea and malaria and data for infant and child mortality, but authors stated that these outcomes will be reported elsewhere. |
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 | Conducted baseline first then allocated villages to intervention arms. |
Baseline imbalance | Low risk | Conducted stratification on average fraction of children aged < 2 years with caregiver‐reported diarrhoea in the previous 7 days; and mean wealth index. |
Loss of clusters | Low risk | No loss of clusters. |
Incorrect analysis | Low risk | Used generalized estimating equations to account for village‐level clustering. |