Gerontology and Health Services Research Unit, Brunel University, London UB8 3PH, UK.
Trials. 2013 Dec 5;14:418. doi: 10.1186/1745-6215-14-418.
BACKGROUND: Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults' most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45-75 year olds to increase their PA over 12 months. DESIGN: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. PARTICIPANTS: Less active 45-75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. INTERVENTION: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care. OUTCOMES: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions' acceptability. DISCUSSION: The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45-75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed. TRIAL REGISTRATION: ISRCTN98538934.
背景:大多数成年人无法达到每周至少进行 150 分钟中等强度活动的推荐量,以促进健康。成年人最常见的体育活动(PA)是步行,如果是散步则强度较低,如果快走则强度适中。计步器可以增加步行量;然而,大多数试验都是短期的,结合了计步器和支持措施,并且没有报告 PA 强度。本试验将研究计步器,无论是否有护士的支持,是否可以帮助不活跃的 45-75 岁人群在 12 个月内增加其 PA。
设计:基于初级保健的三臂随机对照试验,随访 12 个月,并进行健康经济学和定性评估。
参与者:将从六家伦敦西南部的普通诊所通过邮寄的方式招募不活跃的 45-75 岁人群(n=993),每个家庭最多两人,家庭随机分为三组。通过加速度计在基线、3 个月和 12 个月时评估 7 天的步数和不同 PA 强度的时间。将完成问卷调查和人体测量评估。
干预:单独使用计步器组将收到一个计步器(Yamax Digi-Walker SW-200)、手册和日记,详细说明一个基于 12 周计步器的步行计划,使用基线评估的目标。计步器加支持组将额外接受三次实践护士 PA 咨询。手册、日记和咨询包括行为改变技术(例如,自我监测、设定目标、预防复发计划)。对照组将接受常规护理。
结果:通过加速度计测量,12 个月时平均每日步数的变化(主要结果)、久坐时间和至少中等强度 PA 的每周时间。其他结果包括体重指数、体脂、自我报告的 PA、生活质量、情绪和不良事件的变化。将通过干预措施对国民保健服务的增量成本和每步变化的增量成本以及每质量调整生命年的增量成本来评估成本效益。定性评估将探讨试验不参与的原因和干预措施的可接受性。
讨论:PACE-UP 试验将确定通过邮寄或实践护士向 45-75 岁不活跃的初级保健患者提供基于计步器的步行干预的有效性和成本效益。将讨论最小化偏差的方法和预计在交付过程中遇到的挑战。
试验注册:ISRCTN98538934。
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