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Open Access Highly Accessed Study protocol

The Early Prevention of Obesity in CHildren (EPOCH) Collaboration - an Individual Patient Data Prospective Meta-Analysis

Lisa M Askie1*, Louise A Baur2, Karen Campbell3, Lynne A Daniels4, Kylie Hesketh3, Anthea Magarey5, Seema Mihrshahi4, Chris Rissel6, John Simes1, Barry Taylor7, Rachael Taylor8, Merryn Voysey1, Li Ming Wen6 and EPOCH Collaboration1

Author Affiliations

1 NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

2 Discipline of Paediatrics and Child Health, University of Sydney, Sydney, NSW, Australia

3 School of Exercise and Nutrition Sciences, Deakin University, Melbourne, VIC, Australia

4 School of Public Health, Queensland University of Technology, Brisbane, QLD, Australia

5 Department of Nutrition and Dietetics, Flinders University, Adelaide, SA, Australia

6 Health Promotion Service, Sydney South West Area Health Service, Sydney, NSW, Australia

7 Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand

8 Edgar National Centre for Diabetes and Obesity Research, Medical and Surgical Sciences, University of Otago, Dunedin, New Zealand

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BMC Public Health 2010, 10:728  doi:10.1186/1471-2458-10-728

Published: 25 November 2010

Abstract

Background

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. 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/Design

The 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.

Discussion

Finalisation 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 number

ACTRN12610000789066