Ferreira 2019.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Study setting: the trial is conducted in Porto Alegre, South of Brazil, which comprises 1.4 million inhabitants. The trial included health centres that are part of the National Health Care System in Brazil, which provides free health care. Families enrolled in these services are predominantly of low‐income status Inclusion criteria: pregnant women in the last trimester were identified and were invited to participate and were enrolled in the study as potential mothers to receive dietary counselling provided by health workers. Births from May 2008 to February 2009 were included in the study Exclusion criteria (for cluster): ≤ 100 infant patient visits in 2006, staff sharing between clinics or participation in other contemporaneous community‐based dietary programmes Exclusion criteria (for participants): women reporting a positive HIV test were excluded because of concerns of HIV transmission via breastfeeding A total of 617 infants were enrolled, of whom 317 (168 males) were in the intervention group and 300 (157 males) in the no intervention group. There was no difference in baseline demographics |
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| Interventions | Intervention group: a standardised training session was conducted by an experienced nutritionist for the healthcare team to outline the "Ten Steps" recommendations and strategies and to incorporate these into follow‐up consultations. Health workers received 2 printed materials, as developed by the main researcher, which were delivered to mothers during follow‐up consultations Control group: routine care with no material provided to the healthcare worker |
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| Outcomes | Any breastfeeding at 6 to 9 months | |
| Identification | Sponsorship source: Ministry of Health (No. 577/200) and Fundacao de Amparo a Pesquisa do Rio Grande do Sul (PPSUS/2006/1537‐7) Author's name: V.R. Ferreira Institution: Universidade Federal de Ciencias Email: vivianrodrigues_17@hotmail Address: Universidade Federal de Cienciasda Saude de Porto Alegre (UFCSPA), Nucleo de Pesquisa em Nutricao, Sarmento Leite 245, Porto Alegre 90050‐340, RS, Brasil |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Following a stratified randomisation scheme, health centres were block‐randomised by district, with one health centre per district allocated to the intervention and another to the control group" It is unclear from this statement how the sequence was generated, although it would be fair to assume that it was computer generated |
| Allocation concealment (selection bias) | Low risk | Quote: "Of the 31 eligible health centres, 16 were initially selected via a witnessed drawing, by the principal investigator, by labelled markers from an opaque container" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding is not possible for this intervention. Outcome of reported breastfeeding can be influenced by awareness of treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Trained field workers, who were not involved in the intervention and who were unaware of group allocation, conducted maternal interviews using questionnaires at baseline (in pregnancy), during home visits at 6 months (range 5–9 months) and at 12 months (range 11– 15 months)" However, outcome of reported breastfeeding can be influenced by awareness of treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 545 of 715 (76%) infants completed the study. 79% vs 74% of infants in the intervention vs control group completed the study with reason 'not found' in 12.7% and 9.2% in intervention and control groups, respectively |
| Selective reporting (reporting bias) | Low risk | All proposed outcomes were reported |
| Other bias | Low risk | There was no difference in baseline demographics |