Abstract

BackgroundEfforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life. Randomised controlled trials (RCTs) of interventions are even more powerful when, with forethought, they are synthesised into an individual patient data (IPD) prospective meta-analysis (PMA). An IPD PMA is a unique research design where several trials are identified for inclusion in an analysis before any of the individual trial results become known and the data are provided for each randomised patient. This methodology minimises the publication and selection bias often associated with a retrospective meta-analysis by allowing hypotheses, analysis methods and selection criteria to be specified a priori.Methods/DesignThe Early Prevention of Obesity in CHildren (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine if early intervention for childhood obesity impacts on body mass index (BMI) z scores at age 18-24 months. Additional research questions will focus on whether early intervention has an impact on children's dietary quality, TV viewing time, duration of breastfeeding and parenting styles. This protocol includes the hypotheses, inclusion criteria and outcome measures to be used in the IPD PMA. The sample size of the combined dataset at final outcome assessment (approximately 1800 infants) will allow greater precision when exploring differences in the effect of early intervention with respect to pre-specified participant- and intervention-level characteristics.DiscussionFinalisation of the data collection procedures and analysis plans will be complete by the end of 2010. Data collection and analysis will occur during 2011-2012 and results should be available by 2013.Trial registration numberACTRN12610000789066

Highlights

  • Efforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life

  • The main questions that will be addressed by the Early Prevention of Obesity in CHildren (EPOCH) Collaboration are: 1. Do early intervention programs designed to prevent childhood obesity, compared with usual care, offer clinically important benefits in terms of lower body mass index (BMI) z scores at age 18-24 months; higher prevalence of breastfeeding; better children’s dietary quality; less child TV viewing time and higher prevalence of parenting styles and feeding practices that are consistent with effective self regulation and development of healthy weight status? 2

  • Funding bodies must provide support on condition that they will not have any input into the protocol design, data collection, data analysis or in any decisions to publish the results of the EPOCH Collaboration or any of the individual trials

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Summary

Background

Primary prevention of childhood overweight is an international priority [1]. In Australia in 2007, 18-21% of 2-8 year olds were already overweight, including 4-6% who were obese [2]. The 2005 Cochrane Review of interventions for preventing childhood obesity included 22 quality trials, only three of which included children less than five years of age [10]. Other potential effect modifiers A range of other factors influence the development of excess weight gain in childhood and may, in turn, modify responses to obesity prevention interventions. These include birth weight (both low and high birth weight) [33]; lower socioeconomic status [34]; parental, and especially maternal, body mass index (BMI) [35]; and maternal smoking during pregnancy [35]. The Early Prevention of Obesity in CHildren (EPOCH) collaboration was formed in 2009 with the objective of conducting an IPD PMA of these trials to provide the necessary evidence regarding the efficacy of

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21. Birch LL
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