Lombard Catherine B, Harrison Cheryce L, Kozica Samantha L, Zoungas Sophia, Keating Catherine, Teede Helena J
Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
BMC Public Health. 2014 Jun 16;14:608. doi: 10.1186/1471-2458-14-608.
To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.
Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program.
Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally.
ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012.
为应对肥胖流行问题，迫切需要采取能防止人群体重增加的干预措施。然而，即使是最有效的干预措施，除非能在不同人群和环境中成功实施，否则对预防肥胖的影响也微乎其微。实施研究将孤立的疗效研究应用于实践和政策中，在肥胖预防领域尤为重要，因为迫切需要加快从证据到实践的循环。尽管已认识到这一需求，但在现实生活环境中实施的肥胖预防干预措施很少，据我们所知，很少针对农村社区。
在此，我们描述了一项针对生活在农村小社区的女性的健康生活方式项目（HeLP-her Rural）的基本原理、设计和实施情况。HeLP-her Rural的主要目标是通过低强度的自我管理干预措施来防止体重增加。来自澳大利亚42个农村小社区的600名女性将被随机分组（n = 21个对照城镇和n = 21个干预城镇）。采用务实的随机对照试验方法来测试疗效，并通过全面的混合方法社区评估和成本分析来了解这一新型预防项目的有效性和实施情况。
实施预防肥胖的人群干预措施复杂、成本高且具有挑战性。为克服这些障碍，基于证据的干预措施需要超越孤立的疗效试验，并报告与有效性和实施相关的结果。大型务实试验为了解有效性和实施情况提供了机会，从而有可能在人群层面产生更大影响。务实试验应纳入有效性和实施结果以及多维方法，以为扩大到人群层面提供依据。该试验的经验教训将影响国内和国际人群肥胖预防策略的设计和实施。
澳大利亚和新西兰临床试验注册中心ACTRN12612000115831。注册日期2012年1月24日。
