BackgroundLong-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.ObjectiveThe 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.DesignA two-arm cluster randomised controlled trial, including a cost-effectiveness analysis and process evaluation.SettingTransport depots throughout the Midlands region of the UK.ParticipantsHeavy goods vehicle drivers.InterventionThe 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.Main outcome measuresOutcome 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.ResultsA 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).LimitationsA 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.ConclusionThe 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.Future workFurther 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.Trial registrationThis trial is registered as ISRCTN10483894.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 10, No. 12. See the NIHR Journals Library website for further project information.