Dataset Information

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).

ABSTRACT:

Background

Long distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent 'Structured Health Intervention For Truckers' (SHIFT), compared to usual care, at 6- and 16-18-month follow-up.

Methods

We conducted a two-arm cluster RCT in transport sites throughout the Midlands, UK. Outcome measures were assessed at baseline, at 6- and 16-18-month follow-up. Clusters were randomised (1:1) following baseline measurements to either the SHIFT arm or usual practice control arm. The 6-month SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a 'cab workout'). The primary outcome was device-assessed physical activity (mean steps/day) at 6 months. Secondary outcomes included the following: device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables. Data were analysed using mixed-effect linear regression models using a complete-case population.

Results

Three hundred eighty-two HGV drivers (mean ± SD age: 48.4 ± 9.4 years, BMI: 30.4 ± 5.1 kg/m², 99% male) were recruited across 25 clusters (sites) and randomised into either the SHIFT (12 clusters, n = 183) or control (13 clusters, n = 199) arms. At 6 months, 209 (55%) participants provided primary outcome data. Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022). Favourable differences were also seen in the SHIFT group, relative to the control group, in time spent sitting (- 24 mins/day, 95% CI: - 43 to - 6), and moderate-to-vigorous physical activity (6 mins/day, 95% CI: 0.3-11). Differences were not maintained at 16-18 months. No differences were observed between groups in the other secondary outcomes at either follow-up.

Conclusions

The SHIFT programme led to a potentially clinically meaningful difference in daily steps, between trial arms, at 6 months. Whilst the longer-term impact is unclear, the programme offers potential to be incorporated into driver training courses to promote activity in this at-risk, underserved and hard-to-reach essential occupational group.

Trial registration

ISRCTN10483894 (date registered: 01/03/2017).

SUBMITTER: Clemes SA

PROVIDER: S-EPMC9126630 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).

Clemes Stacy A SA Varela-Mato Veronica V Bodicoat Danielle H DH Brookes Cassandra L CL Chen Yu-Ling YL Edwardson Charlotte L CL Gray Laura J LJ Guest Amber J AJ Johnson Vicki V Munir Fehmidah F Paine Nicola J NJ Richardson Gerry G Ruettger Katharina K Sayyah Mohsen M Sherry Aron A Di Paola Ana Suazo AS Troughton Jacqui J Yates Thomas T King James A JA

BMC medicine 20220524 1

<h4>Background</h4>Long distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent 'Structured Health Intervention For Truckers' (SHIFT), compared to usual care, at 6- and 16-18-month follow-up.<h4>Methods</h4>We conducted a two-arm cluster RCT in transport sites througho ...[more]

PMID: 35606763

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Project description:IntroductionHeavy 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 analysisHGV 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 disseminationEthical 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 numberISRCTN10483894.

Project description:ObjectivesTo evaluate the impact of a multicomponent intervention (Stand More AT (SMArT) Work) designed to reduce sitting time on short (three months), medium (six months), and longer term (12 months) changes in occupational, daily, and prolonged sitting, standing, and physical activity, and physical, psychological, and work related health.DesignCluster two arm randomised controlled trial.SettingNational Health Service trust, England.Participants37 office clusters (146 participants) of desk based workers: 19 clusters (77 participants) were randomised to the intervention and 18 (69 participants) to control.InterventionsThe intervention group received a height adjustable workstation, a brief seminar with supporting leaflet, workstation instructions with sitting and standing targets, feedback on sitting and physical activity at three time points, posters, action planning and goal setting booklet, self monitoring and prompt tool, and coaching sessions (month 1 and every three months thereafter). The control group continued with usual practice.Main outcome measuresThe primary outcome was occupational sitting time (thigh worn accelerometer). Secondary outcomes were objectively measured daily sitting, prolonged sitting (≥30 minutes), and standing time, physical activity, musculoskeletal problems, self reported work related health (job performance, job satisfaction, work engagement, occupational fatigue, sickness presenteeism, and sickness absenteeism), cognitive function, and self reported psychological measures (mood and affective states, quality of life) assessed at 3, 6, and 12 months. Data were analysed using generalised estimating equation models, accounting for clustering.ResultsA significant difference between groups (in favour of the intervention group) was found in occupational sitting time at 12 months (-83.28 min/workday, 95% confidence interval -116.57 to -49.98, P=0.001). Differences between groups (in favour of the intervention group compared with control) were observed for occupational sitting time at three months (-50.62 min/workday, -78.71 to -22.54, P<0.001) and six months (-64.40 min/workday, -97.31 to -31.50, P<0.001) and daily sitting time at six months (-59.32 min/day, -88.40 to -30.25, P<0.001) and 12 months (-82.39 min/day, -114.54 to -50.26, P=0.001). Group differences (in favour of the intervention group compared with control) were found for prolonged sitting time, standing time, job performance, work engagement, occupational fatigue, sickness presenteeism, daily anxiety, and quality of life. No differences were seen for sickness absenteeism.ConclusionsSMArT Work successfully reduced sitting time over the short, medium, and longer term, and positive changes were observed in work related and psychological health.Trial registrationCurrent Controlled Trials ISRCTN10967042.

Project description:ObjectiveTo evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.DesignPragmatic cluster randomised controlled trial.SettingPrimary care practices in the north east and south east of England and in London.Participants3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.InterventionsPractices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.Main outcome measuresThe primary outcome was patients' self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients' motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.ResultsPatient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.ConclusionsAll patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.Trial registrationCurrent Controlled Trials ISRCTN06145674.

Project description:ObjectivesTo evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes.DesignCluster three arm randomised controlled trial with follow-up at three and 12 months.SettingLocal government councils in Leicester, Liverpool, and Greater Manchester, UK.Participants78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool.InterventionsClusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice).Main outcomes measuresThe primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures.ResultsMean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support.ConclusionsBoth SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective.Trial registrationISRCTN Registry ISRCTN11618007.

Project description:PurposeA barrier for reemployment of people with mental health issues/mental illness (MHI) is workplace stigma and discrimination. In this RCT the effectiveness of a stigma-awareness intervention addressing finding work, retaining work and decisional stress were evaluated.MethodsA cluster RCT was conducted in 8 Dutch municipal practices. Randomisation took place at practice level. Participants were unemployed people with MHI, receiving social benefits. The intervention consisted of a decision aid for workplace disclosure for participants and a 2 × 3 h stigma-awareness training for their employment specialists. Primary outcomes were measured at baseline, 3-, 6- and 12-months. Multilevel analyses, containing random intercepts of participants nested in organizations, were conducted to analyse the effects of the intervention.ResultsParticipants (N = 153) were randomized to an experimental (n = 76) or control group (n = 77). At six months, significantly more participants of the experimental group (51%) had found work compared to the control group (26%). At twelve months, significantly more participants of the experimental group (49%) had retained work compared to the control group (23%). Intention-to-treat analyses showed that randomization to the experimental group was associated with finding (OR(95%CI) = 7.78(1.33-45.53), p = 0.02) and retaining (OR(95%CI) = 12.15(2.81-52.63), p < 0.01) work more often at twelve months. Analyses showed that the experimental and control group did not differ in decisional stress.ConclusionsOur stigma awareness intervention was effective for finding and retaining work. As the percentage of people who found and retained work almost doubled, this suggests that on a societal level, a vast number of unemployed people could be reemployed with a relatively simple intervention.Trial registrationThe study was retrospectively registered at the Dutch Trial Register (TRN: NL7798, date: 04-06-2019).

Project description:IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20-29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

Project description:IntroductionPeople with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.Methods and analysisA multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months.Ethics and disseminationThe protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.Trial registration numberISRCTN 61215213.

Project description:OBJECTIVES:To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns. TRIAL DESIGN:Two-arm cluster randomised controlled trial. METHODS:Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ≤35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group). INTERVENTIONS:intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches. OUTCOME MEASURES:primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment. RESULTS:Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed). OUTCOME:K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI -1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups. CONCLUSIONS:the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development. TRIAL REGISTRATION NUMBER:ACTRN12613000041752; Pre-results.

Dataset Information

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).

Background

Methods

Results

Conclusions

Trial registration

Publications

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).

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