Bortolini 2012.
Study characteristics | ||
Methods | RCT | |
Participants | Study setting: Sao Leopoldo, state of Rio Grande do Sul, Brazil Inclusion criteria: all infants born in the Brazilian National Health Service wards of the Hospital Centenario between October 2001 and June 2002 at birth weight ≥ 2500 grams and at gestational age ≥ 37 weeks Exclusion criteria: HIV‐positive mothers, congenital malformations, newborns admitted to intensive care units, multiple delivery, infants with serum haemoglobin levels < 110 g/L at 6 months of age Initially 500 infants were enrolled (200 in intervention group and 300 in control group), of whom 197 and 272 received the allocated treatment. A total of 397 infants were followed up, of whom 163 (93 (57.1%) males) were in the nutritional counselling group and 234 (130 (55.5%) males) were in the no intervention group |
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Interventions | Intervention group: nutritional messages based on "Ten Steps for Healthy Feeding in Children Younger Than Two Years" Counselling by 10 home visits: first 10 days of birth, monthly up to 6 months, and at 8, 10, and 12 months Control group: families were visited at 6 and 12 months for collection of anthropometric, dietary, and socio‐demographic data |
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Outcomes | Prevalence of exclusive breastfeeding at 6 months Prevalence of anaemia (serum haemoglobin < 110 g/L) at the age of 12 months |
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Identification | ||
Notes | Some information was extracted from other publications of the same study (Vitolo 2005 and Costa 2017). Google translation was used to translate the article from Portuguese to English | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (Costa 2017): "mothers who agreed to participate were sequentially listed on the basis of their time of delivery, grouped in blocks of five, and their names separated in opaque, sealed envelopes. Two mothers from each block were randomly assigned to the intervention group, and the remaining three mothers were allocated to the control group" However, the method of randomisation is not given in any of the publications |
Allocation concealment (selection bias) | Low risk | As above |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The intervention is not amenable to blinding of participants or of personnel delivering the intervention. One outcome considered in this review (serum haemoglobin level) is unlikely to be affected by lack of blinding, but the other (prevalence of exclusive breastfeeding) is highly likely to be affected by knowledge of treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This report indicates that outcome assessors were blind Quote: "interviewers who were not involved in the intervention process and who were blind to which group children belonged conducted home visits at 6 and 12 months in order to collect data on the study variables" However, the statement in Vitolo 2005 suggests that interviewers were not blind to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 397 (79.4%) of the 500 randomised infants were included in the final analysis. A similar percentage of infants were lost to follow‐up in both intervention (37 (19%)) and control groups (66 (22%)) |
Selective reporting (reporting bias) | Low risk | The protocol for this study is available: some outcomes, such as effectiveness of a nutrition advice programme for occurrence of diarrhoea, respiratory problems, use of dental caries, and hospitalisation, were not reported. However, all proposed outcomes relevant to this review have been reported |
Other bias | Low risk |