Warren Janet M, Golley Rebecca K, Collins Clare E, Okely Anthony D, Jones Rachel A, Morgan Philip J, Perry Rebecca A, Baur Louise A, Steele Julie R, Magarey Anthea M
University of Newcastle, Schools of Health Sciences and Education, Callaghan Campus, Newcastle, New South Wales, Australia.
Int J Pediatr Obes. 2007;2(2):73-85. doi: 10.1080/17477160601133671.
To highlight and discuss the practical aspects of conducting high quality, randomised controlled trials (RCTs) with overweight and obese children and their families.
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.
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.
强调并讨论针对超重及肥胖儿童及其家庭开展高质量随机对照试验（RCT）的实际问题。
重点介绍了来自澳大利亚三项针对超重/肥胖儿童干预措施的经验给研究人员带来的现实考量与建议。此类随机对照试验中出现的关键问题的实际影响包括研究设计、获得伦理批准、结局指标的选择、招募、与家庭合作、影响及过程评估、保留策略、多中心试验管理和数据管理。
针对超重儿童及其家庭的干预具有挑战性。尽管三项研究在设计和结局指标上存在一些差异，但也有许多相似之处。多中心试验虽然比单中心试验成本更高，但在增加样本量和外部效度方面具有优势。我们共同制定了应对开展随机对照试验关键问题的策略，包括招募、保留以及与家庭合作等常见挑战。
