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Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial

机译:评估英格兰NHS健康检查中的非常简短的计步器的身体活动干预:VBI随机对照试验

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Background The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention (‘Step It Up’) delivered as part of National Health Service (NHS) Health Checks in primary care. Methods and findings The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants’ mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI ?18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study’s limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment. Conclusions In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up. Trial registration Current Controlled Trials (ISRCTN72691150).
机译:背景,大多数人没有实现建议的身体活动水平。需要有效,可扩展的干预措施来促进活动。通过计步器自我监控是一种潜在的合适策略。我们评估了非常简单(5分钟)的基于计步器的干预('Step It Up')作为国家卫生服务(NHS)初级保健检查的一部分提供的有效性和成本效益。方法和调查结果非常简短干预(VBI)试验是两个平行组,随机对照试验(RCT),其中3个月随访,在英格兰东的23个初级保健实践中进行。参与者是40至74岁的1,007名健康成年人,符合NHS健康检查。它们在2014年10月1日至2015年10月1日至2015年12月31日之间随机分配(1:1),介入(505)或对照组(502),由初级保健实践分层。参与者了解学习团体分配。控制参与者仅收到NHS健康检查。干预参与者另外收到阶梯:5分钟的面对面讨论,书面材料,计步器和平面图。主要结果是加速度计的体育率为3个月的后续行动,调整为性行为,5年年龄组和一般做法。二次结果包括在不同的身体活动,自我报告的身体活动和经济措施中花费时间。我们对健康检查磋商的附带进行了深入的富达评估。参与者的平均年龄为56岁,女性三分之二是女性,他们主要是白色,三分之二是有偿就业。主要成果有859名(85.3%)参与者。在3个月内,活性体积的组差异无显着之间(调整干预效果8.8每分钟计数[CPM]; 95%CI?18.7至36.3; P = 0.53)。我们发现在步骤计数的二次结果中差异无明显差异,在中等或剧烈活动中花费的时间,在剧烈活动中花费的时间和中等强度活动所花费的时间(加速度计导出的变量);以及总体活动,家庭活动,基于工作的活动,休闲活动,通勤身体活动和屏幕或电视时间(自我报告的物理活动变量)。在505个干预参与者中,491名(97%)收到了阶梯的干预。分析37个干预咨询表明,迈出了60%的阶梯组件忠实地交付。每个参与者的干预费用为18.04英镑。每1,000步的NHS每天增加的成本为96英镑,社会为239英镑。通过5个干预参与者(其中2个严重)和5个控制参与者(其中2个严重)的5个控制参与者报告不良事件。该研究的局限性包括富达评估的实践的参与率16%,录音带返回呼吸。结论在这一大型进行了良好的审判中,我们发现没有任何合理的非常简短的计步器干预的证据,嵌入NHS Health核实在3个月的随访时间上的客观测量活动。试验登记目前对照试验(ISRCTN72691150)。

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