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一项三臂群组随机对照试验,旨在测试 SMART 工作与生活干预在减少上班族日常久坐时间方面的有效性和成本效益:研究方案。

A three arm cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the SMART Work & Life intervention for reducing daily sitting time in office workers: study protocol.

机构信息

Diabetes Research Centre, University of Leicester, Leicester, UK.

NIHR Leicester Biomedical Research Centre, Leicester, UK.

出版信息

BMC Public Health. 2018 Sep 14;18(1):1120. doi: 10.1186/s12889-018-6017-1.

Abstract

BACKGROUND

Office-based workers typically spend 70-85% of working hours, and a large proportion of leisure time, sitting. High levels of sitting have been linked to poor health. There is a need for fully powered randomised controlled trials (RCTs) with long-term follow-up to test the effectiveness of interventions to reduce sitting. This paper describes the methodology of a three-arm cluster RCT designed to determine the effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable desk, for reducing daily sitting.

METHODS/DESIGN: A three-arm cluster RCT of 33 clusters (660 council workers) will be conducted in three areas in England (Leicester; Manchester; Liverpool). Office groups (clusters) will be randomised to the SMART Work & Life intervention delivered with (group 1) or without (group 2) a height-adjustable desk or a control group (group 3). SMART Work & Life includes organisational (e.g., management buy-in, provision/support for standing meetings), environmental (e.g., relocating waste bins, printers), and group/individual (education, action planning, goal setting, addressing barriers, coaching, self-monitoring, social support) level behaviour change strategies, with strategies driven by workplace champions. Baseline, 3, 12 and 24 month measures will be taken.

PRIMARY OUTCOME

Objectively measured daily sitting time (activPAL3).

SECONDARY OUTCOMES

objectively measured sitting, standing, stepping, prolonged sitting and moderate-to-vigorous physical activity time and number of steps at work and daily; objectively measured sleep (wrist accelerometry). Adiposity, blood pressure, fasting glucose, glycated haemoglobin, cholesterol (total, HDL, LDL) and triglycerides will be assessed from capillary blood samples. Questionnaires will examine dietary intake, fatigue, musculoskeletal issues, job performance and satisfaction, work engagement, occupational and general fatigue, stress, presenteeism, anxiety and depression and sickness absence (organisational records). Quality of life and resources used (e.g. GP visits, outpatient attendances) will also be assessed. We will conduct a full process evaluation and cost-effectiveness analysis.

DISCUSSION

The results of this RCT will 1) help to understand how effective an important simple, yet relatively expensive environmental change is for reducing sitting, 2) provide evidence on changing behaviour across all waking hours, and 3) provide evidence for policy guidelines around population and workplace health and well-being.

TRIAL REGISTRATION

ISRCTN11618007 . Registered on 21 January 2018.

摘要

背景

办公室工作人员通常在工作中 70-85%的时间和大部分休闲时间都坐着。高水平的久坐与健康状况不佳有关。需要进行充分动力的随机对照试验(RCT),并进行长期随访,以测试减少久坐的干预措施的有效性。本文描述了一项三臂群组 RCT 的方法学设计,该 RCT 旨在确定 SMART Work & Life 干预措施的有效性和成本效益,该干预措施与(第 1 组)或不与(第 2 组)可调节高度的办公桌一起提供,用于减少日常久坐时间。

方法/设计:在英格兰的三个地区(莱斯特;曼彻斯特;利物浦)进行了一项三臂群组 RCT,涉及 33 个群组(660 名议会工作人员)。办公群组(群组)将被随机分配到 SMART Work & Life 干预措施中,该措施与可调节高度的办公桌一起提供(第 1 组)或不提供(第 2 组)或对照组(第 3 组)。SMART Work & Life 包括组织(例如,管理层支持,提供/支持站立会议)、环境(例如,重新定位垃圾桶、打印机)和小组/个人(教育、行动计划、设定目标、解决障碍、指导、自我监测、社会支持)层面的行为改变策略,策略由工作场所的拥护者推动。将在基线、3、12 和 24 个月时进行测量。

主要结果

客观测量的每日久坐时间(activPAL3)。

次要结果

客观测量的坐、站、走、长时间坐和中高强度体力活动时间和工作和日常的步数;手腕加速计评估的睡眠(手腕加速计)。将从毛细血管血样中评估体脂、血压、空腹血糖、糖化血红蛋白、胆固醇(总胆固醇、HDL、LDL)和甘油三酯。问卷调查将检查饮食摄入、疲劳、肌肉骨骼问题、工作表现和满意度、工作投入、职业和一般疲劳、压力、出勤、焦虑和抑郁以及病假(组织记录)。还将评估生活质量和使用的资源(例如,GP 就诊、门诊就诊)。我们将进行全面的过程评估和成本效益分析。

讨论

该 RCT 的结果将 1)有助于了解一种重要的简单但相对昂贵的环境改变对减少久坐的有效性,2)提供关于改变所有清醒时间行为的证据,3)为人口和工作场所健康和福祉的政策指南提供证据。

试验注册

ISRCTN81320551。于 2018 年 1 月 21 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0db3/6137871/65762f46f9ea/12889_2018_6017_Fig1_HTML.jpg

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