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Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol
  1. Stacy A Clemes1,
  2. Verónica Varela Mato1,
  3. Fehmidah Munir1,
  4. Charlotte L Edwardson2,
  5. Yu-Ling Chen1,
  6. Mark Hamer1,
  7. Laura J Gray3,
  8. Nishal Bhupendra Jaicim4,
  9. Gerry Richardson5,
  10. Vicki Johnson6,
  11. Jacqui Troughton6,
  12. Thomas Yates2,
  13. James A King1
  1. 1 School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK
  2. 2 Diabetes Research Centre, University of Leicester, Leicester, UK
  3. 3 Department of Health Sciences, University of Leicester, Leicester, UK
  4. 4 Leicester Clinical Trials Unit, University of Leicester, Leicester, UK
  5. 5 Centre for Health Economics, University of York, York, UK
  6. 6 Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
  1. Correspondence to Dr Stacy A Clemes; s.a.clemes{at}lboro.ac.uk

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.

  • public health
  • preventive medicine
  • physical activity
  • sedentary behaviour
  • health promotion
  • occupational drivers

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Twitter @StacyClemes

  • Contributors All authors have made substantial contributions to the concept and design of the study. The study was conceived by SAC, VVM, JAK, TY, CLE, MH, FM, LJG, JT, VJ and GR. VVM, VJ and Y-LC are the qualified Research Associates on the project. LJG and NBJ are the trial statisticians and developed the statistical analysis plan and GR developed the cost-effectiveness plan. The first draft of this manuscript was written by SAC with input from all other authors. All authors have edited and critically reviewed the paper for intellectual content and approved the final version of the paper.

  • Funding This study is funded by the NIHR Public Health Research Programme (reference: NIHR PHR 15/190/42) and supported by the NIHR Leicester Biomedical Research Centre – Lifestyle theme. Funding to cover intervention costs (Fitbits, cab workout equipment) has been received from the Higher Education Innovation Fund via the Loughborough University Enterprise Projects Group.

  • Competing interests None declared.

  • Patient consent for publication Not required.

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

  • Provenance and peer review Not commissioned; externally peer reviewed.