Abstract
Aim. To highlight and discuss the practical aspects of conducting high quality, randomised controlled trials (RCTs) with overweight and obese children and their families. Content. Realistic considerations and suggestions for researchers arising from the experiences of three Australian interventions in overweight/obese children are highlighted. The practical implications of key issues arising during this type of RCT include study design, obtaining ethical approval, choice of outcome measures, recruitment, working with families, impact and process evaluation, retention strategies, managing multi-site trials and data management. Conclusion. Interventions for overweight children and their families are challenging. Although there were some differences in the design and outcome measures among the three studies, there were many similarities. Multi-site trials, although more expensive than single-site trials, are advantageous in increasing sample size and external validity. Collectively we have developed strategies to address key problems in conducting RCTs, including the common challenges of recruitment, retention and working with families.
Acknowledgements
The HELPP study was funded by the Australian Health Management Group Medical Research Fund and ongoing monitoring is funded by the Foundation for Children.
The HIKCUPS and PEACH studies are funded by Australian NHMRC project grants (#354101 & #272226). Rebecca Golley was supported by an NHMRC Postgraduate Research Scholarship (#229978) and Rebecca Perry was funded by a National Health Foods PhD Scholarship in Childhood Obesity (2004) and currently by an NHMRC Public Health Postgraduate Scholarship (#375184). We thank Professor Lynne Daniels, Associate Professor Kate Steinbeck, Professor Kevin Norton and Professor Michael Sawyer, who are additional chief investigators for the HELPP and/or PEACH studies. We also thank the PEACH study site managers, Anthea Lee and Gizelle Wilson; the HIKCUPS study investigators and research students, Tracy Burrows, Dylan Cliff and Jane Cleary; and Sanitarium Health Food Company who provided breakfast for children in the HIKCUPS study. Finally, we are extremely grateful to all study participants and their families.