The SMILE project will apply an observational prospective study design to follow a cohort of socioeconomically-diverse South Australian newborns and their primary care-givers (mothers will be used in this paper from here on), from birth until they reach toddler age. A multivariable, multilevel approach will be applied to data collection and analysis. The timeline and main groups of outcome and explanatory variables are outlined in Table 1.
The project has received ethical approval from the Southern Adelaide Clinical Human Research Ethics Committee (HREC # 50.13, approval date: 28 Feb 2013), the South Australian Women and Children Health Network (HREC # HREC/13/WCHN/69, approval date: 7 Aug 2013) and clinical governance clearance from the three participating maternity hospitals in Adelaide, Australia.
The study participant recruitment has commenced since July 2013 and is expected to last 12 months. The 3-month and 6-month data collection is ongoing.
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