Nikiema 2017.
Study characteristics | ||
Methods | Cluster‐RCT | |
Participants | Study setting: health district of Hounde, located 250 km west of Ouagadougou, Burkina Faso's capital city Inclusion criteria: a cohort of pregnant women in their third trimester was prospectively recruited from each cluster. Pregnant women were eligible for inclusion if they had no intention of leaving the study area for the next 2 years and provided informed written consent. Eligible pregnant women were identified through antenatal consultations (women attending their third antenatal visit) and were included until the desired sample size was reached at each health centre Exclusion criteria: only 1 infant from multiple pregnancy was included. Infants with major birth defects were excluded 2253 infants were recruited from 12 clusters of a primary healthcare catchment area |
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Interventions | Intervention group: individual nutrition counselling was provided to all women attending intervention centres during pregnancy and during the first 18 months of their child's life. Counselling contacts were scheduled to begin during pregnancy and to continue until the child reached 18 months of age. At each contact, health providers used a patient‐centred approach to explore the caregiver's and the child's situation and current feeding practices, and to identify their specific needs in terms of nutrition, health advice, and curative care | |
Outcomes | Height‐for‐age z score at 12 and 18 months of age, respectively Weight‐for‐height z score at 12 and 18 months, respectively Exclusive breastfeeding at 6 months of age |
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Identification | ||
Notes | No major differences were noted in baseline characteristics | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | For each pair of health centres, 2 identical pieces of paper were numbered corresponding to each health centre and were put into a basket. A volunteer not involved in the study was asked to choose a paper for the intervention centre |
Allocation concealment (selection bias) | Low risk | As above |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded due to the nature of the intervention. However, anthropometric assessments are unlikely to be affected by lack of blinding. On the other hand, the other outcome considered in this review (duration of exclusive breastfeeding) is dependent on parental report and may be affected by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Data collection was performed by trained field workers not involved in intervention delivery who were not blind to the intervention. However, anthropometric assessments are unlikely to be affected by lack of blinding. On the other hand, the other outcome considered in this review (duration of exclusive breastfeeding) is dependent on parental report and may be affected by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | Overall 67.5% children were lost to follow‐up, with 68.6% and 66.3% in the intervention and control arms, respectively. No significant difference was reported between the 2 study arms in the distribution of children lost to follow‐up. However, reasons for loss to follow‐up were not reported |
Selective reporting (reporting bias) | Low risk | There was no deviation from the published protocol |
Other bias | Low risk | No difference in baseline characteristics was noted in the intervention and control arms, respectively |