Vazir 2013.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Setting: villages in Andhra Pradesh, India Inclusion criteria: clusters with population size of at least 1000; all pregnant women in the third trimester of pregnancy in participating villages were enrolled and infants followed up from 3 to 12 months of age 210 pregnant women were enrolled in the nutrition education group and 202 in the control group. At baseline, there were 207 (100 (48%) males) infants in the intervention group and 199 (117 (51%) males) in the control group |
|
| Interventions | Intervention group: routine Integrated Child Development Services (ICDS) and 11 nutrition education messages based on sustained breastfeeding and complementary feeding twice or 4 times a month home visits over 12 months Control group: routine ICDS services only |
|
| Outcomes | Change in weight and height between 6 and 12 months WAZ and HAZ at 12 and 15 months The paper reports weights at 6 and 12 months On request, study authors provided data on change in weight between 6 and 12 months (mean, SD) and on WAZ and HAZ at 12 and 15 months |
|
| Identification | ||
| Notes | Study had 2 intervention groups: nutrition education and nutrition education + responsive play. For this review, we have used data from control and nutrition education groups only | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "the random allocation using a random number generator", using computer software |
| Allocation concealment (selection bias) | Low risk | Quote: "allocation was undertaken by a researcher who was not familiar with the villages or their characteristics" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No information was provided. However, the intervention is not amenable to blinding of participants nor personnel delivering the intervention; outcomes included in this review are unlikely to be affected by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the assessment teams were blinded to the intervention and had no interaction with the village women" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | At 12 months, 375 (91.0%) babies had growth parameters measured that were included in this review |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available, but all proposed outcomes were reported |
| Other bias | Low risk | |