Peacock Oliver J, Western Max J, Batterham Alan M, Stathi Afroditi, Standage Martyn, Tapp Alan, Bennett Paul, Thompson Dylan
Department for Health, University of Bath, Bath, BA2 7AY, UK.
Health and Social Care Institute, Teesside University, Middlesbrough, UK.
Trials. 2015 Aug 28;16:381. doi: 10.1186/s13063-015-0892-x.
Low physical activity is a major public health problem. New cost-effective approaches that stimulate meaningful long-term changes in physical activity are required, especially within primary care settings. It is becoming clear that there are various dimensions to physical activity with independent health benefits. Advances in technology mean that it is now possible to generate multidimensional physical activity 'profiles' that provide a more complete representation of physical activity and offer a variety of options that can be tailored to the individual. Mi-PACT is a randomised controlled trial designed to examine whether personalised multidimensional physical activity feedback and self-monitoring alongside trainer-supportive sessions increases physical activity and improves health outcomes in at-risk men and women.
METHODS/DESIGN: We aim to recruit 216 patients from within primary care aged 40 to 70 years and at medium or high risk of cardiovascular disease and/or type II diabetes mellitus. Adopting an unequal allocation ratio (intervention: control) of 2:1, participants will be randomised to one of two groups, usual care or the intervention. The control group will receive usual care from their general practitioner (GP) and standardised messages about physical activity for health. The intervention group will receive physical activity monitors and access to a web-based platform for a 3-month period to enable self-monitoring and the provision of personalised feedback regarding the multidimensional nature of physical activity. In addition, this technology-enabled feedback will be discussed with participants on 5 occasions during supportive one-to-one coaching sessions across the 3-month intervention. The primary outcome measure is physical activity, which will be directly assessed using activity monitors for a 7-day period at baseline, post intervention and at 12 months. Secondary measures (at these time-points) include weight loss, fat mass, and markers of metabolic control, motivation and well-being.
Results from this study will provide insight into the effects of integrated physical activity profiling and self-monitoring combined with in-person support on physical activity and health outcomes in patients at risk of future chronic disease.
ISRCTN18008011 Trial registration date: 31 July 2013.
身体活动不足是一个重大的公共卫生问题。需要新的具有成本效益的方法来刺激身体活动产生有意义的长期变化，尤其是在初级保健环境中。越来越明显的是，身体活动具有多个维度，每个维度都对健康有益。技术的进步意味着现在有可能生成多维度的身体活动“档案”，更全面地反映身体活动情况，并提供各种可根据个人情况量身定制的选项。Mi-PACT是一项随机对照试验，旨在研究个性化多维度身体活动反馈和自我监测，以及培训师支持课程，是否能增加有风险的男性和女性的身体活动并改善健康结果。
方法/设计：我们的目标是从40至70岁、患有心血管疾病和/或II型糖尿病中度或高度风险的初级保健患者中招募216名患者。采用2:1的不等分配比例（干预组：对照组），参与者将被随机分为两组之一，即常规护理组或干预组。对照组将从其全科医生（GP）处接受常规护理，并收到关于身体活动对健康有益的标准化信息。干预组将在3个月内获得身体活动监测器并可访问基于网络的平台，以实现自我监测并提供关于身体活动多维度性质的个性化反馈。此外，在为期3个月的干预期间，将在一对一的支持性辅导课程中与参与者讨论5次这种基于技术的反馈。主要结局指标是身体活动，将在基线、干预后和12个月时使用活动监测器直接评估7天的身体活动情况。次要指标（在这些时间点）包括体重减轻、脂肪量以及代谢控制、动机和幸福感的指标。
本研究的结果将深入了解综合身体活动档案和自我监测以及面对面支持对未来有慢性病风险患者的身体活动和健康结果的影响。
ISRCTN18008011。试验注册日期：2013年7月31日。
