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. 2015 Dec 15;2015(12):CD009916. doi: 10.1002/14651858.CD009916.pub2

Morris 2004.

Methods Cluster‐randomized controlled trial. 24 months. The intervention "Programa de Asginaction Familiar" identified 70 communities with highest rates of malnutrition in rural Honduras, which were randomized into 4 groups: 20 to control, 20 to household‐level package, 10 to service‐level package, and 20 to dual‐package. A randomly selected number of households within each group were administered both a pre‐ and post‐intervention survey. Comparison was to pregnancies that occurred within household‐level package and control groups.
Participants Within household‐level and dual‐level groups, the eligible households were those which had a pregnant woman, child under age 3 or child between age 6‐12 at time of 2000 census. 5545 households participated in the pre‐intervention survey, including 1605 in the control group, 1574 in the household‐level package, 786 in the service‐level package, and 1580 in the dual‐package. 5289 of these households participated in the post‐intervention survey, including 1524 in the control group, 1512 in the household‐level package, 744 in the service‐level package, and 1509 in the dual‐package.
Interventions Within household‐level package communities, eligible households could receive vouchers equal to cash for each pregnant woman, child under age 3 or child between age 6‐12 who was enrolled in school, dependent on regular prenatal and well‐child preventive care as well as regular school attendance. Service‐level package communities received quality improvement teams aimed at strengthening health centers and community‐based nutrition programs. Dual‐package communities received both household‐level and service‐level interventions.
Outcomes Primary outcomes included adequate use of prenatal care (defined as at least 5 visits), postpartum checkup within 10 days of delivery and children < 3 years taken to health center within past 30 days. Secondary outcomes included immunization rates and growth monitoring.
Notes Service‐level package was only fully implemented in 17% of selected communities due to difficulty in transferring specified resources from the government to the community‐based teams responsible for implementation. Teams were able to implement community‐based nutrition programs, but most were not able to implement the individual‐based nutrition counseling as intended.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Cluster‐randomization by community. Communities were stratified by degree of malnutrition. Communities within each stratum were randomized to intervention group by a child blindly drawing colored balls from a box without replacement.
Allocation concealment (selection bias) Low risk Community was aware of intervention. However, households could not become eligible for vouchers by moving into household‐level community after time of randomization.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No attempt to conceal intervention after time of randomization.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Baseline and post‐intervention surveys administered by independent data collection company which was aware of community intervention grouping.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat.
Selective reporting (reporting bias) Low risk Reporting consistent with protocol.
Other bias Low risk Honduran government commissioned an independent evaluation of program impact, which was funded with the assistance of a loan from the Inter‐American Development Bank.