Cluster randomization and intervention allocation
MALNOURISHED
The study followed cluster randomization to allocate the subjects for intervention and control groups. There are 106 villages in the district. Considering the average number of children registered in the Anganwadi center and sample size calculation, the study required 12 villages to be selected. The sampling frame of all the villages was prepared and by lottery method, 12 clusters (villages) were allocated to the intervention and control groups (six clusters each) randomly. All the Anganwadi centers belonging to these villages and all malnourished preschool children and their mothers who met inclusion criteria were enrolled in the study. Thus 127 preschool children and their mothers from 27 Anganwadi centers of six villages were chosen for the intervention group, and 126 preschool children and their mothers from 30 Anganwadi centers of six villages were enrolled in the control arm. The schematic presentation of the cRCT followed the guidelines of CONSORT 2010 [CONSORT (2010) flow diagram of the study