PEDIATRIC REVIEW A proposed protocol for the development of a register of trials of weight management of childhood overweight and obesity KS Steinbeck 1 , LA Baur 2 , AM Morris 2 and D Ghersi 3 1 Endocrinology and Adolescent Medicine & Faculty of Medicine, University of Sydney, Level 5, King George V Building, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; 2 University of Sydney Discipline of Paediatrics & Child Health, The Children’s Hospital at Westmead, Locked Bag 4001, Westmead, NSW, Australia and 3 National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown NSW, Australia Introduction: Currently, there is no international co-ordinated approach to research into childhood obesity. This is despite much research activity in this area and the universality of the condition. Method: This proposal involves the development of an international register of randomized controlled trials of weight management in overweight and obese children. The primary purpose of the register will be to generate and perform important, focussed prospective meta-analysis of data from trials using the conventional weight management strategies. Prospective meta- analysis is an emerging methodology and has some methodological advantages over retrospective meta-analysis. Proposal: The fundamental initial tasks will be to create scientific interest in the proposal, to identify and co-ordinate Management and Advisory Committees with international membership, to determine and define inclusion and exclusion criteria for trial registration, to define the questions that need to be addressed by prospective meta-analysis and finally to engage investigators to register. International Journal of Obesity (2006) 30, 2–5. doi:10.1038/sj.ijo.0803169 Keywords: childhood obesity; prospective meta-analysis; trial registry Introduction Child and adolescent overweight and obesity is increasing worldwide and has serious public health consequences. 1 Effective treatment of childhood overweight and obesity not only improves physical and psychological health during childhood but is an important component of community wide prevention of adult obesity. The conventional weight-management strategies are the following: reduction in energy intake by dietary means; increase in energy expenditure by increasing physical activity and decreasing sedentary activity; and modification of behaviours and habits associated with eating and activity, all of which include family involvement in the process of behaviour change. 2 Much research has been conducted in this area over many years; however, two systematic reviews of the literature have been unable to produce recommenda- tions for management. 3,4 This is in part due to the wide variation in setting, population, outcome measures and ways of implementing the weight management strategies. The Cochrane review by Summerbell et al. 4 clearly demonstrates the heterogeneous nature of the research to date. In this review, which included 18 trials, it was not possible to perform conventional meta-analysis of any results due to the differences in the type of intervention and outcome measures reported. In addition, the sample size of each trial was generally small. In conclusion, the authors stated that ‘no direct conclusions can be drawn from this review with confidence.’ This lack of data was also acknowledged in the WHO Consultation on obesity 5 which stated: ‘A much needed research step is to conduct a longitudinal trial that evaluates whether results like those achieved by Epstein and colleagues can be replicated at other sites and in other populations, and whether tangible health benefits, both in the health and social domains, can be demonstrated.’ Further, three recently published national guidelines (from Singapore, Scotland and Australia) on the management of obesity in childhood were Received 20 September 2005; accepted 7 October 2005 Correspondence: Professor K Steinbeck, Endocrinology and Adolescent Medicine, Level 5, King George V Building, Royal Prince Alfred Hospital, Camperdown, NSW 2050 Australia. E-mail: kss@email.cs.nsw.gov.au International Journal of Obesity (2006) 30, 2–5 & 2006 Nature Publishing Group All rights reserved 0307-0565/06 $30.00 www.nature.com/ijo