Bhandari 2004.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Study setting: rural communities in the state of Haryana, India Inclusion criteria: infants born between October 1999 and June 2000 if they were "local residents and informed written consent was obtained" Exclusion criteria: none given 8 cluster including a total of 1025 infants enrolled, of whom 552 (288 (52.2%) males) infants in 4 clusters were in the nutritional counselling group and 473 (253 (53.5%) males) in 4 clusters were in the no intervention group |
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| Interventions | Intervention group: locally relevant nutritional messages were developed by formative research; messages were discussed in monthly home visits up to 12 months and in 3‐month visits up to 2 years Control group received routine services, which included advice on initiation of complementary feeding at 4 to 6 months, types of foods to be fed, and frequency of feeding, but the focus was on family planning and immunisation |
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| Outcomes | Weight gain between 6 and 12 months of age Increase in length between 6 and 12 months of age Prevalence of exclusive breastfeeding at 6 months |
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| Identification | ||
| Notes | The intervention was continued until the child was 2 years of age. For this review, we have extracted data only up to the first year of life | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "generated 4 single‐digit random numbers using a random numbers table; the first listed community in a pair was allocated to the intervention group if the random number was 0–4 and the second if it was 5–9" |
| Allocation concealment (selection bias) | Low risk | A statistician not involved with the study performed the randomisation (i.e. there was central allocation using random number tables) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The intervention is not amenable to blinding of participants or of personnel delivering the intervention; however, outcomes included in this review are unlikely to be affected by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | There was an attempt to blind personnel who collected outcome data Quote: ‘‘mothers and infants were visited at home by workers who were not involved in the delivery of the intervention at 3, 6, 9, 12, 15, and 18 months of age’’ Also, outcomes included in this review are unlikely to be affected by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | High risk | The number of infants followed up at 12 months is not reported. However, attrition at both 9 months and 18 months was > 10%. At 9 months, 451 (81.2%) in the intervention group and 403 (85.2%) in the control group were followed up. The numbers followed up were further reduced at 18 months: 435 (78.8%) in intervention group and 394 (83.3%) in control group. There also appears to be imbalance in the reasons for loss to follow‐up. There were 26 (4.7%) deaths, 13 (2.4%) refusals, and 78 (14.1%) in the intervention group as reasons for loss to follow‐up as compared to 12 (2.5%), 5 (1.1%), and 62 (13.1%), respectively, in the control group |
| Selective reporting (reporting bias) | Low risk | Although the study protocol is not available, all proposed outcome measures were reported |
| Other bias | Low risk | |