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. |
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Interventions | Intervention: 3 arms
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. |
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Outcomes | Primary outcomes:
Secondary outcomes:
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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 |
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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. |