一项多组分结构化健康行为干预以改善长途HGV驾驶员的身体活动:SHIFT集群随机对照试验

S. Clemes, V. Varela-Mato, D. Bodicoat, C. Brookes, Yu-Ling Chen, Edward Cox, C. Edwardson, L. Gray, A. Guest, Vicki Johnson, F. Munir, Nicola J. Paine, G. Richardson, K. Ruettger, Mohsen Sayyah, A. Sherry, Ana Suazo Di Paola, J. Troughton, Simon Walker, T. Yates, James A King
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The working environment of heavy goods vehicle drivers provides limited opportunities for a healthy lifestyle, and, consequently, heavy goods vehicle drivers exhibit higher than nationally representative rates of obesity and obesity-related comorbidities, and are underserved in terms of health promotion initiatives.\n \n \n \n The aim of this trial was to test the effectiveness and cost-effectiveness of the multicomponent Structured Health Intervention For Truckers (SHIFT) programme, compared with usual care, at both 6 months and 16–18 months.\n \n \n \n A two-arm cluster randomised controlled trial, including a cost-effectiveness analysis and process evaluation.\n \n \n \n Transport depots throughout the Midlands region of the UK.\n \n \n \n Heavy goods vehicle drivers.\n \n \n \n The 6-month SHIFT programme included a group-based interactive 6-hour education session, health coach support and equipment provision [including a Fitbit® (Fitbit Inc., San Francisco, CA, US) and resistance bands/balls to facilitate a ‘cab workout’]. Clusters were randomised following baseline measurements to either the SHIFT arm or the control arm.\n \n \n \n Outcome measures were assessed at baseline, with follow-up assessments occurring at both 6 months and 16–18 months. The primary outcome was device-measured physical activity, expressed as mean steps per day, at 6-month follow-up. Secondary outcomes included device-measured sitting, standing, stepping, physical activity and sleep time (on any day, workdays and non-workdays), along with adiposity, biochemical measures, diet, blood pressure, psychophysiological reactivity, cognitive function, functional fitness, mental well-being, musculoskeletal symptoms and work-related psychosocial variables. Cost-effectiveness and process evaluation data were collected.\n \n \n \n A total of 382 participants (mean ± standard deviation age: 48.4 ± 9.4 years; mean ± standard deviation body mass index: 30.4 kg/m2 ± 5.1 kg/m2; 99% male) were recruited across 25 clusters. Participants were randomised (at the cluster level) to either the SHIFT arm (12 clusters, n = 183) or the control arm (13 clusters, n = 199). At 6 months, 209 (54.7%) participants provided primary outcome data. Significant differences in mean daily steps were found between arms, with participants in the SHIFT arm accumulating 1008 more steps per day than participants in the control arm (95% confidence interval 145 to 1871 steps; p = 0.022), which was largely driven by the maintenance of physical activity levels in the SHIFT arm and a decline in physical activity levels in the control arm. Favourable differences at 6 months were also seen in the SHIFT arm, relative to the control arm, in time spent sitting, standing and stepping, and time in moderate or vigorous activity. No differences between arms were observed at 16–18 months’ follow-up. No differences were observed between arms in the other secondary outcomes at either follow-up (i.e. 6 months and 16–18 months). The process evaluation demonstrated that the intervention was well received by participants and that the intervention reportedly had a positive impact on their health behaviours. The average total cost of delivering the SHIFT programme was £369.57 per driver, and resulting quality-adjusted life-years were similar across trial arms (SHIFT arm: 1.22, 95% confidence interval 1.19 to 1.25; control arm: 1.25, 95% confidence interval 1.22 to 1.27).\n \n \n \n A higher (31.4%) than anticipated loss to follow-up was experienced at 6 months, with fewer (54.7%) participants providing valid primary outcome data at 6 months. 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引用次数: 1

摘要

长途重型货车司机会接触到与其职业相关的多种风险因素。重型货车司机的工作环境为健康生活方式提供了有限的机会,因此,重型货车司机表现出比全国代表性更高的肥胖和肥胖相关合并症发病率,在健康促进举措方面服务不足。该试验的目的是测试卡车司机多组分结构化健康干预(SHIFT)计划在6个月和16-18个月时与常规护理相比的有效性和成本效益。一项双臂集群随机对照试验,包括成本效益分析和过程评估。遍布英国中部地区的运输站。重型货车司机。为期6个月的SHIFT计划包括6小时的小组互动教育课程、健康教练支持和设备供应[包括Fitbit®(美国加利福尼亚州旧金山Fitbit股份有限公司)和阻力带/球,以促进“驾驶室锻炼”]。集群在基线测量后被随机分配到SHIFT臂或对照臂。结果测量在基线时进行评估,随访评估在6个月和16-18个月进行。主要结果是在6个月的随访中,设备测量的体力活动,表示为每天的平均步数。次要结果包括设备测量的坐、站、步、身体活动和睡眠时间(在任何一天、工作日和非工作日),以及肥胖、生物化学测量、饮食、血压、心理生理反应、认知功能、功能健康、心理健康、肌肉骨骼症状和与工作相关的心理社会变量。收集成本效益和工艺评估数据。共有382名参与者(平均 ± 标准差年龄:48.4 ± 9.4年;意思是 ± 标准偏差体重指数:30.4 kg/m2 ± 5.1 kg/m2;99%的男性)在25个集群中被招募。参与者被随机分配到SHIFT组(12组,n = 183)或控制臂(13个簇 = 199)。在6个月时,209名(54.7%)参与者提供了主要结果数据。两组之间的平均每日步数存在显著差异,SHIFT组的参与者每天比对照组多累积1008步(95%置信区间145至1871步;p = 0.022),这在很大程度上是由SHIFT臂中的体力活动水平的维持和控制臂中的体能活动水平的下降所驱动的。在6个月时,相对于对照组,SHIFT组在坐、站和走的时间以及中等或剧烈活动的时间方面也出现了有利的差异。在16–18个月的随访中,未观察到两组之间的差异。在任何一次随访(即6个月和16-18个月)中,在其他次要结果方面,各组之间均未观察到差异。过程评估表明,干预措施受到了参与者的好评,据报道,干预措施对他们的健康行为产生了积极影响。实施SHIFT方案的平均总成本为每位驾驶员369.57英镑,由此产生的质量调整生命年在试验组中相似(SHIFT组:1.22,95%置信区间1.19至1.25;对照组:1.25,95%置信间隔1.22至1.27)。6个月时的随访损失(31.4%)高于预期,在6个月时提供有效主要结果数据的参与者较少(54.7%)。新冠肺炎大流行是一个主要的混淆因素,这限制了我们就SHIFT计划的可持续性得出坚定结论的能力。SHIFT方案在一定程度上成功地对体力活动水平产生了积极影响,并将重型货车司机的坐着时间减少了6个月;然而,这些差异在16-18个月时没有保持。需要利益相关者参与的进一步工作,以根据当前的调查结果完善该计划的内容,然后将SHIFT计划转化为可扩展的驾驶员培训资源。本试验注册号为ISRCTN10483894。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第12期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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A multicomponent structured health behaviour intervention to improve physical activity in long-distance HGV drivers: the SHIFT cluster RCT
Long-distance heavy goods vehicle drivers are exposed to a multitude of risk factors associated with their occupation. The working environment of heavy goods vehicle drivers provides limited opportunities for a healthy lifestyle, and, consequently, heavy goods vehicle drivers exhibit higher than nationally representative rates of obesity and obesity-related comorbidities, and are underserved in terms of health promotion initiatives. The aim of this trial was to test the effectiveness and cost-effectiveness of the multicomponent Structured Health Intervention For Truckers (SHIFT) programme, compared with usual care, at both 6 months and 16–18 months. A two-arm cluster randomised controlled trial, including a cost-effectiveness analysis and process evaluation. Transport depots throughout the Midlands region of the UK. Heavy goods vehicle drivers. The 6-month SHIFT programme included a group-based interactive 6-hour education session, health coach support and equipment provision [including a Fitbit® (Fitbit Inc., San Francisco, CA, US) and resistance bands/balls to facilitate a ‘cab workout’]. Clusters were randomised following baseline measurements to either the SHIFT arm or the control arm. Outcome measures were assessed at baseline, with follow-up assessments occurring at both 6 months and 16–18 months. The primary outcome was device-measured physical activity, expressed as mean steps per day, at 6-month follow-up. Secondary outcomes included device-measured sitting, standing, stepping, physical activity and sleep time (on any day, workdays and non-workdays), along with adiposity, biochemical measures, diet, blood pressure, psychophysiological reactivity, cognitive function, functional fitness, mental well-being, musculoskeletal symptoms and work-related psychosocial variables. Cost-effectiveness and process evaluation data were collected. A total of 382 participants (mean ± standard deviation age: 48.4 ± 9.4 years; mean ± standard deviation body mass index: 30.4 kg/m2 ± 5.1 kg/m2; 99% male) were recruited across 25 clusters. Participants were randomised (at the cluster level) to either the SHIFT arm (12 clusters, n = 183) or the control arm (13 clusters, n = 199). At 6 months, 209 (54.7%) participants provided primary outcome data. Significant differences in mean daily steps were found between arms, with participants in the SHIFT arm accumulating 1008 more steps per day than participants in the control arm (95% confidence interval 145 to 1871 steps; p = 0.022), which was largely driven by the maintenance of physical activity levels in the SHIFT arm and a decline in physical activity levels in the control arm. Favourable differences at 6 months were also seen in the SHIFT arm, relative to the control arm, in time spent sitting, standing and stepping, and time in moderate or vigorous activity. No differences between arms were observed at 16–18 months’ follow-up. No differences were observed between arms in the other secondary outcomes at either follow-up (i.e. 6 months and 16–18 months). The process evaluation demonstrated that the intervention was well received by participants and that the intervention reportedly had a positive impact on their health behaviours. The average total cost of delivering the SHIFT programme was £369.57 per driver, and resulting quality-adjusted life-years were similar across trial arms (SHIFT arm: 1.22, 95% confidence interval 1.19 to 1.25; control arm: 1.25, 95% confidence interval 1.22 to 1.27). A higher (31.4%) than anticipated loss to follow-up was experienced at 6 months, with fewer (54.7%) participants providing valid primary outcome data at 6 months. The COVID-19 pandemic presents a major confounding factor, which limits our ability to draw firm conclusions regarding the sustainability of the SHIFT programme. The SHIFT programme had a degree of success in positively impacting physical activity levels and reducing sitting time in heavy goods vehicle drivers at 6-months; however, these differences were not maintained at 16–18 months. Further work involving stakeholder engagement is needed to refine the content of the programme, based on current findings, followed by the translation of the SHIFT programme into a scalable driver training resource. This trial is registered as ISRCTN10483894. This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 12. See the NIHR Journals Library website for further project information.
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审稿时长
46 weeks
期刊最新文献
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