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68 At the end of 4 weeks, invitation kits will be mailed out to service users and carers from participating clusters.
All pregnant women and their home- or facility-born live births within participating clusters will be eligible for enrollment in this study.
A declaration will be signed by the representatives of the participating clusters which should be posted in the nursing homes' foyers.
The primary outcome is the difference in the perinatal mortality rate (fresh stillbirths or neonatal deaths prior to 7 days after birth) among births ≥1500 grams across the three participating clusters pre vs. post intervention.
The DCC randomized participating clusters within each country to either the lyophilized meat or cereal intervention using toddler stunting rates as the matching criterion; all clusters had stunting rates greater than 20%.
The order in which the different surgery wards will receive the program is determined at random, allowing the full implementation of intervention in all participating clusters by the end of the trial [ 24].
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Numbers of included patients per participating cluster ranged from 11 to 79 patients.
The study is a stepped wedge cluster randomised controlled trial in which participating schools (clusters) cross over from control to intervention phase (i.e. one-way switch over) at different time points throughout the school year.
The coordinator of each participating HA cluster and clinic are asked to complete a structure of care questionnaire (Additional file 4).
The randomization of study subjects was not done at random, but the 33 participating clinics (cluster randomization) were randomized to carry out the intervention according to one of the four specified intervention protocols (diet alone, exercise alone, diet-exercise combined, or none).
We have been supporting community mobilisation through women's groups in the district since 2001, and from 1st November 2001 to 31st October 2003, 24 Village Development Committee clusters participated in a cluster randomised controlled trial testing the impact of women's groups on neonatal mortality [ 21].
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