坐立式办公桌可减少9至10岁儿童的久坐行为:课堂上脱颖而出的试点集群RCT

S. Clemes, D. Bingham, N. Pearson, Yu-Ling Chen, C. Edwardson, R. McEachan, K. Tolfrey, Lorraine A Cale, G. Richardson, M. Fray, James Altunkaya, S. Bandelow, N. B. Jaicim, S. Barber
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A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. 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引用次数: 7

摘要

背景久坐行为(久坐)是一种非常普遍的负面健康行为,所有年龄段的人都暴露在促进久坐的环境中。学校教室通过提供坐立式办公桌,为环境变化提供了理想的环境。目的本研究的目的是进行一项试点集群随机对照试验,在小学课堂上引入坐立式办公桌,为最终试验提供信息。目标包括提供关于学校和参与者招募和保留、干预的可接受性以及结果衡量的信息。计算了干预措施对纳入最终试验的拟议主要结果(工作日坐着时间的变化)的有效性的初步估计,以及对潜在成本效益的初步评估。还进行了全过程评估。设计一项具有经济和定性评价的双臂试点集群随机对照试验。学校在1:1的基础上被随机分配到干预组(n=4)或对照组(n=4)试验组。设置英国西约克郡布拉德福德的小学。参与者为5年级(即9-10岁)的儿童。干预六张坐立式办公桌取代了干预教室里的三张标准办公桌(坐着六个孩子),持续了4.5个月。鼓励教师使用轮换制度,确保所有学生平均每天至少接触1小时的坐立式课桌。被分配到控制部门的学校继续他们的常规做法。主要结果测量试验可行性结果包括学校和参与者的招募和流失、干预的可接受性、拟议结果测量的可接受度和依从性[包括使用activPAL测量的工作日静坐™ (英国格拉斯哥PAL技术有限公司)加速度计、身体活动、肥胖、血压、认知功能、肌肉骨骼舒适度、学业进步、参与度和行为]。结果33%的学校报名,75%(n=176)符合条件的儿童参加。在7个月的随访中,学校和儿童的保留率分别为100%和97%。结果测量完成率在63%到97%之间。根据加权线性回归模型(调整基线坐着时间和穿着时间)对干预有效性的初步估计显示,干预试验组和对照试验组之间的平均坐着变化差异为每天-30.6分钟(95%置信区间为每天56.42至-4.84分钟)。过程评估显示,干预、招聘和评估程序对教师和儿童来说是可以接受的,但与活动依恋有关的小问题除外。一项初步的试验内经济分析显示,干预试验组和对照试验组在卫生和教育资源使用或结果方面没有差异。长期建模估计,每增加一个质量调整生命年,杰出学生的未调整增量成本效益比为78986英镑。结论本研究为课堂突出干预和评价方法的可接受性和可行性提供了证据。初步证据表明,干预措施可能对工作日的久坐时间产生积极影响,这需要在全组随机对照试验中进行测试。从这次试验中吸取的经验教训将为最终试验的计划提供信息。试验注册当前对照试验ISRCTN12915848。资助该项目由国家卫生研究所(NIHR)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8卷,第8期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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Sit–stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT
Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.
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来源期刊
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11
审稿时长
46 weeks
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