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. 2018 May 18;2018(5):CD011768. doi: 10.1002/14651858.CD011768.pub2

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)
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%)
Interventions Intervention (see Table 4 for detailed description):
  1. large group education

  2. feeding demonstrations


Control: treatment as usual (routine services)
Duration of each intervention session: not reported
Outcomes
  1. Effect on physical growth (weights and lengths)

  2. Complementary feeding practices (effects of the types of food fed to children, responsive feeding, hygiene practices)

  3. Prevalence of diarrhoea


Not used in this review:
  1. prevalence of cough

  2. prevalence of fever


Time points reported: weights and lengths at 6, 12 and 18 months, and complementary feeding practices at 9 and 18 months
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)
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