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. 2020 Jul 25;2020(7):CD012241. doi: 10.1002/14651858.CD012241.pub2

Saleem 2014.

Study characteristics
Methods Cluster‐RCT
Participants Setting: Bin Qasim Town, Karachi, Pakistan
Between June 2001 and July 2002
Inclusion criteria: mothers of infants aged 10 to 20 weeks' gestation who were exclusively or partially breastfed but had not started or had recently started (< 1 week before enrolment) complementary feeding
Exclusion criteria: all infants with weight for age < 5th centile as per the WHO growth chart, history of 2 or more hospital admissions, serious congenital anomalies, other chronic conditions impairing feeding, or presence of acute illness and/or severe anaemia that required urgent hospital treatment
A total of 212 infants were recruited (118 in the intervention group and 94 in the control group), but baseline data were reported on 110 infants and 84 infants in the 2 groups, respectively
Interventions Intervention group: 4 visits (baseline and then at 10 weekly intervals) with 10 key messages developed on WHO/UNICEF recommended practices: importance of breastfeeding continuation for 2 years, hygiene, complementary feeding initiation at 6 months, advice on promoting protein and iron‐rich complementary foods
The intervention continued for 6 months with education messages provided once a week for the first 3 months and then once every 2 weeks for the next 3 months
Control: regular BINP services
Outcomes Weight
Length
Mid‐upper arm circumference
WAZ, HAZ, and WHZ at 10 weeks, 20 weeks, and 30 weeks after intervention
Age at which measurement was done was not standardised or reported
Identification  
Notes Insufficient outcome data (age at which measurement was done) were reported for us to include the study in the review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 10 geographically distinct areas were randomly assigned via a random numbers table to educational intervention and control
Allocation concealment (selection bias) Unclear risk This was not described in the article
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk This was not described in the article
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk This was not described in the article
Incomplete outcome data (attrition bias)
All outcomes Low risk 170 (80.2%) infants were followed up until the end of the study, comprising 95 (80.5%) and 75 (79.8%) infants in intervention and control groups, respectively, with similar proportions of infants dropped out for various reasons including migrated (20 and 15), refused length measurement (2 and 3), and violated study protocol (1 and 1) for intervention and control groups, respectively
Selective reporting (reporting bias) Low risk All proposed outcomes were reported
Other bias High risk Infants in the intervention group were younger at 106.5 ± 22.4 days (mean ± standard deviation) as compared to 113.7 ± 24.5 days in the control group, with higher mid‐upper arm circumference of 12.5 ± 0.9 cm as compared to 12.2 ± 1.1 cm in the control group. A higher rate of illiteracy was noted in the control group (67%) vs the intervention group (47%)