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一项旨在探究针对卡车司机的结构化健康干预措施(SHIFT 研究)有效性和成本效益的整群随机对照试验:研究方案。

Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol.

机构信息

School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK

School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.

出版信息

BMJ Open. 2019 Nov 24;9(11):e030175. doi: 10.1136/bmjopen-2019-030175.

DOI:10.1136/bmjopen-2019-030175
PMID:31767581
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6886973/
Abstract

INTRODUCTION

Heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.

METHODS AND ANALYSIS

HGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout'). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.

TRIAL REGISTRATION NUMBER

ISRCTN10483894.

摘要

简介

与其他职业群体相比,重型货车(HGV)驾驶员的肥胖率以及与肥胖相关的合并症发生率均高于全国代表性水平。他们的工作环境不利于健康的生活方式,但对健康促进工作的关注有限。我们开发了一种针对 HGV 驾驶员的结构化健康干预措施(SHIFT 计划),这是一种多成分、基于理论的健康行为干预措施,针对的是体力活动、饮食和久坐行为。本文描述了一项集群随机对照试验的方案,旨在评估 SHIFT 计划的有效性和成本效益。

方法与分析

将从英国的一家物流公司招募 HGV 驾驶员。在进行基线测量后,将(集群)车 depot 随机分配到 SHIFT 干预组或常规护理对照组(每组 12 个,每个集群平均有 14 名驾驶员)。为期 6 个月的 SHIFT 干预措施包括一个基于小组的互动式 6 小时教育课程、工作场所冠军支持和设备提供(包括 Fitbit 和阻力带/球,以促进“驾驶室锻炼”)。总日常体力活动的客观测量(步数/天)将是主要结果。次要结果包括:客观测量的低强度体力活动和中高强度体力活动、久坐时间、睡眠质量、肥胖标志物、血压和毛细血管血液标志物(糖化血红蛋白、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇)。自我报告问卷将调查水果和蔬菜摄入量、心理社会和工作结果以及心理健康。还将评估生活质量和使用的资源(例如,全科医生就诊)。将在基线、6 个月和 12 个月时收集测量值,并根据修改后的意向治疗原则进行分析。将进行全面的过程评估和成本效益分析。

伦理与传播

拉夫堡大学伦理审批小组委员会已批准该研究(参考编号:R17-P063)。研究结果将通过在研究和专业期刊上发表文章、会议演讲以及通过在线媒体和传播活动向相关地区和国家利益相关者传播。

试验注册号

ISRCTN86201544。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/6886973/652897addc3d/bmjopen-2019-030175f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/6886973/cadba9bfdbbd/bmjopen-2019-030175f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/6886973/652897addc3d/bmjopen-2019-030175f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/6886973/cadba9bfdbbd/bmjopen-2019-030175f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/6886973/652897addc3d/bmjopen-2019-030175f02.jpg

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