Bhandari 2004.
Methods | Design: cluster‐RCT Unit of randomisation: communities Intention to treat: yes Adjustment for clustering: yes. Quote: "All results reported are adjusted for cluster randomisation (using the “cluster” option of the “regress” command)" (p 2344) |
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Participants | Number: 8 communities with 1025 newborn infants (intervention: 552; control: 473) Inclusion criteria: newborns enrolled if they were local residents and informed written consent was obtained Exclusion criteria: not stated Age: newborns enrolled and followed up every 3 months up to the age of 18 months Gender: intervention: 52.2% male, 47.8% female; control: 53.5% male, 46.5% female Ethnicity: not reported Settings: State of Haryana Country: India Attrition: intervention: 117/552 (21.2%); control: 79/473 (16.7%) |
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Interventions | Intervention (see Table 4 for detailed description):
Control: treatment as usual (routine services) Duration of each intervention session: not reported |
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Outcomes |
Not used in this review:
Time points reported: weights and lengths at 6, 12 and 18 months, and complementary feeding practices at 9 and 18 months |
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Notes | Study start and end dates: not reported Study duration: 18 months Conflict of interest: not stated Source of funding: "supported by the Department of Child and Adolescent Health and Development, World Health Organization, Geneva, Switzerland" (quote, p 2342) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: sequence was generated using random numbers table (see p 2344) |
Allocation concealment (selection bias) | Low risk | Quote: "a statistician, not involved with the study, generated 4 single‐digit random numbers using a random numbers table" (p 2344) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described, probably not done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described, probably not done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: more than 10% loss (196/1025) but "all analyses were by intention to treat" (quote, p 2344) |
Selective reporting (reporting bias) | Unclear risk | Comment: none observed. No protocol available |
Other bias | Low risk | Comment: none observed |