The effectiveness and cost-effectiveness of a structured health intervention for truckers (The SHIFT Study)

INTERVENTION: This study involves two phases: an internal pilot and the full study. Participants are allocated to clusters which are randomised to receive either the six month "SHIFT programme" or the usual care (control). Clusters are randomised at the worksite level and takes place in two phases: The first six clusters (n=84) are involved in the internal pilot and the second phase of the study will begin a year after which consists of the remaining clusters (18 depots, n=252 drivers). In both study phases, randomisation takes place upon completion of baseline measurements. The internal pilot examines issues surrounding worksite and participant recruitment, randomisation, compliance to the primary outcome, and retention rates at 6‐months following randomisation. After the completion of the internal pilot, the remaining depots start the study. In both phases participants undertake a baseline assessment. This takes two hours per driver. After the baseline assessments, participants are given two accelerometers to monitor their physical activity and sitting time levels for 24 hours over a seven day period. The depots involved in the internal pilot are then randomised to either the intervention or the control groups by the Leicester Clinical Trials Unit (CTU). Intervention group (SHIFT): The six month SHIFT intervention, grounded within the Social Cognitive Theory for behaviour change, consists of a group‐based interactive six hour education session tailored for heavy goods vehicle (HGV) drivers, delivered by trained educators. This includes information about physical activity, diet, health factors associated to long periods of sitting, risk factors for type 2 diabetes and cardiovascular disease. The educational component is derived from the award winning DESMOND programme, created by educators at the Leicester Diabetes Centre (LDC) and used throughout the National Health service (NHS). The education session is supported by specially developed resources for HGV drivers and partic CONDITION: Obesity and chronic disease prevention, specifically cardiovascular disease and type 2 diabetes ; Nutritional, Metabolic, Endocrine ; Obesity and chronic disease prevention, specifically cardiovascular disease and type 2 diabetes PRIMARY OUTCOME: Physical activity (steps per day) is measured using the activPAL3 micro accelerometer (worn on the thigh 24 hours a day during the 7 day assessment period) at baseline, 6 months and 12 months. INCLUSION CRITERIA: 1. Long distance heavy goods vehicle (HGV) drivers 2. Aged 18 to 65 years 3. Male and female (with the exception of females who are pregnant) 4. Free of cardiovascular disease, haemophilia, or blood‐borne viruses 5. Must not have any mobility issues which prevent them from going about their normal work duties SECONDARY OUTCOME: 1. Light and moderate‐to‐vigorous physical activity (MVPA) is measured using the GENEActiv accelerometer (worn on the wrist 24 hours a day for the 7 day assessment period at baseline, 6 and 12 months; 2. Sitting time is measured using the activPAL3 micro at baseline, 6 and 12 months; 3. Adiposity measured using the portable Tanita 418 bioelectrical impedance analyser at baseline, 6 and 12 months; 4. Neck circumference is measured using anthropometry tape at baseline, 6 months and 12 months; 5. Blood pressure is measured using automated blood pressure analysers at baseline, 6 and 12 months; 6. Blood markers (total cholesterol, HDL, LDL, glycated haemoglobin) are assessed using a finger‐prick blood sample at baseline, 6 and 12 months; 7. Dietary quality is measured using a short‐form food frequency questionnaire at baseline, 6 and 12 months; 8. Binge eating is measured using The Three‐Factor Eating Questionnaire at baseline, 6 and 12 months; 9. Sleep duration is measured using the GENEActiv for 7 days at baseline, 6 and 12 months; 10. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, 6 and 12 months; 11. Cognitive function is measured using the Stroop test at baseline, 6 and 12 months; 12. Musculoskeletal symptoms are assessed using the Standardised Nordic Questionnaire at baseline, 6 and 12 months; 13. Work engagement (characterised by vigour, dedication, and absorption) will be measured using the Utretcht Work Engagement Scale (UWES) at baseline, 6 and 12 months; 14. Occupational fatigue is measured using the Need for Recovery Scale at baseline, 6 and 12 months; 15. Job performance and job satisfaction is measured using single‐item 7‐point Likert scales at baseline, 6 and 12 months; 16. General quality of life is assessed using the WHO QOL‐BREF at baseline, 6 and 12 months; 17. Presenteeism is assessed using the Work Limitations Questionnaire and the Work Productivity and Activity Impairment Questionnaire (WPAI‐GH 2.0) at baseline, 6 and 12 months; 18. Perceptions of work demand and support are assessed using four subscales from the Health and Safety Executive Management Standards Indicator Tool (HSE MSIT) at baseline, 6 and 12 months; 19. Driving‐related safety behaviour is assessed using a 6‐item measure at baseline, 6 and 12 months; 20. Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 6 and 12 months; 21. Sickness absence is collected via self‐report and employer records and will include frequency and duration of self‐certified and certified sickness at baseline, 6 and 12 months; 22. Cost‐effectiveness and health related resources of the trial is assessed using the self‐reported EQ5D at baseline, 6 and 12 months; 23. Basic demographics (e.g. age, education level, years as a HGV driver) are measured using self‐reported measures at baseline, 6 and 12 months