BMC Public Health Study protocol The Infant Feeding Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: Cluster-randomised controlled trial Karen Campbell1, Kylie Hesketh1, David Crawford1, Jo Salmon1, Kylie Ball1 and Zoë McCallum*2 BioMed Central Open Access Address: 1Centre for Physical Activity and Nutrition Research, Faculty of Health, Medicine, Nursing and Behavioral Sciences, Deakin University, Victoria, Australia and 2Department of Pediatrics, University of Melbourne, Victoria, Australia Email: Karen Campbell - karen.campbell@deakin.edu.au; Kylie Hesketh - kylie.hesketh@deakin.edu.au; David Crawford - dcraw@deakin.edu.au; Jo Salmon - jo.salmon@deakin.edu.au; Kylie Ball - kylie.ball@deakin.edu.au; Zoë McCallum* - zoe.mccallum@rch.org.au * Corresponding author Published: 31 March 2008 BMC Public Health 2008, 8:103 doi:10.1186/1471-2458-8-103 This article is available from: http://www.biomedcentral.com/1471-2458/8/103 Received: 11 February 2008 Accepted: 31 March 2008 © 2008 Campbell et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour) from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT) aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups) and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design: This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion: The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups promotes healthy eating, physical activity and reduced sedentary behaviours. If proven to be effective, INFANT may protect children from the development of obesity and its associated social and economic costs. Trial registration: Current Controlled Trials ISRCTN81847050 Page 1 of 9 (page number not for citation purposes)