Nair 2017.
Study characteristics | ||
Methods | Cluster‐RCT | |
Participants | Study setting: West Singhbhum and Kendujhar ‐ 2 adjoining rural districts of Jharkhand and Odisha in eastern India Inclusion criteria: individual participants were pregnant women identified and recruited in study clusters and their children Exclusion criteria: stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period 3001 infants from 120 geographical clusters were recruited in the study |
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Interventions | Intervention group: community‐based workers conduct a single home visit to each pregnant woman in the third trimester of pregnancy for counselling on maternal nutrition, followed by monthly home visits to all children younger than 2 years with counselling for growth promotion, and facilitate 2 to 3 participatory meetings with local women’s groups per month | |
Outcomes | Change in height in the first 18 months of life Height‐for‐age z score at 18 months of age Weight‐for‐age z score at 18 months of age Weight‐for‐height z score at 18 months of age Exclusive breastfeeding at 6 months of age |
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Identification | ||
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Meeting participants put numbered balls corresponding to clusters in each stratum in a local tombola (lottery device), then sequentially allocated each ball (cluster) to the intervention or control arm |
Allocation concealment (selection bias) | High risk | Due to the nature of the intervention, participants and the intervention team were not masked to allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although participants and personnel were not blinded due to the nature of the intervention, the growth parameters obtained were an objective measure |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The data collection team and the data manager were masked to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The overall follow‐up rate was similar across both intervention and control groups at 86% and 85%, respectively |
Selective reporting (reporting bias) | High risk | There was diversion from protocol on outcomes reported as the number of secondary outcomes was later reduced on the online trial registration form after feedback from the data monitoring committee. The following outcomes in the published protocol were not reported: change in weight from birth to 18 months of age, and mean mid‐upper arm circumference z score at 18 months of age |
Other bias | Low risk | No difference in baseline demographics was reported between groups |