What are the strengths and limitations to utilising creative methods in public and patient involvement in health and social care research? A qualitative systematic review.

BACKGROUND: There is increasing interest in using patient and public involvement (PPI) in research to improve the quality of healthcare. Ordinarily, traditional methods have been used such as interviews or focus groups. However, these methods tend to engage a similar demographic of people. Thus, creative methods are being developed to involve patients for whom traditional methods are inaccessible or non-engaging. OBJECTIVE: To determine the strengths and limitations to using creative PPI methods in health and social care research. METHOD: Electronic searches were conducted over five databases on 14th April 2023 (Web of Science, PubMed, ASSIA, CINAHL, Cochrane Library). Studies that involved traditional, non-creative PPI methods were excluded. Creative PPI methods were used to engage with people as research advisors, rather than study participants. Only primary data published in English from 2009 were accepted. Title, abstract and full text screening was undertaken by two independent reviewers before inductive thematic analysis was used to generate themes. RESULTS: Twelve papers met the inclusion criteria. The creative methods used included songs, poems, drawings, photograph elicitation, drama performance, visualisations, social media, photography, prototype development, cultural animation, card sorting and persona development. Analysis identified four limitations and five strengths to the creative approaches. Limitations included the time and resource intensive nature of creative PPI, the lack of generalisation to wider populations and ethical issues. External factors, such as the lack of infrastructure to support creative PPI, also affected their implementation. Strengths included the disruption of power hierarchies and the creation of a safe space for people to express mundane or "taboo" topics. Creative methods are also engaging, inclusive of people who struggle to participate in traditional PPI and can also be cost and time efficient. CONCLUSION: 'Creative PPI' is an umbrella term encapsulating many different methods of engagement and there are strengths and limitations to each. The choice of which should be determined by the aims and requirements of the research, as well as the characteristics of the PPI group and practical limitations. Creative PPI can be advantageous over more traditional methods, however a hybrid approach could be considered to reap the benefits of both. Creative PPI methods are not widely used; however, this could change over time as PPI becomes embedded even more into research.

It is important that patients and public are included in the research process from initial brainstorming, through design to delivery. This is known as public and patient involvement (PPI). Their input means that research closely aligns with their wants and needs. Traditionally to get this input, interviews and group discussions are held, but this can exclude people who find these activities non-engaging or inaccessible, for example those with language challenges, learning disabilities or memory issues. Creative methods of PPI can overcome this. This is a broad term describing different (non-traditional) ways of engaging patients and public in research, such as through the use or art, animation or performance. This review investigated the reasons why creative approaches to PPI could be difficult (limitations) or helpful (strengths) in health and social care research. After searching 5 online databases, 12 studies were included in the review. PPI groups included adults, children and people with language and memory impairments. Creative methods included songs, poems, drawings, the use of photos and drama, visualisations, Facebook, creating prototypes, personas and card sorting. Limitations included the time, cost and effort associated with creative methods, the lack of application to other populations, ethical issues and buy-in from the wider research community. Strengths included the feeling of equality between academics and the public, creation of a safe space for people to express themselves, inclusivity, and that creative PPI can be cost and time efficient. Overall, this review suggests that creative PPI is worthwhile, however each method has its own strengths and limitations and the choice of which will depend on the research project, PPI group characteristics and other practical limitations, such as time and financial constraints.

Using intervention mapping to develop evidence-based toolkits that support workers on long-term sick leave and their managers.

BACKGROUND: Managing long-term sickness absence is challenging in countries where employers and managers have the main responsibility to provide return to work support, particularly for workers with poor mental health. Whilst long-term sick leave and return to work frameworks and guidance exist for employers, there are currently no structured return to work protocols for employers or for their workers encompassing best practice strategies to support a positive and timely return to work outcome. PURPOSE: To utilise the intervention mapping (IM) protocol as a framework to develop return to work toolkits that are underpinned by relevant behaviour change theory targeting mental health to promote a positive return to work experiensce for workers on long-term sick leave. METHODS: This paper provides a worked example of intervention mapping (IM) to develop an intervention through a six-step process to combine theory and evidence in the development of two toolkits - one designed for managers and one to be used by workers on long-term sick leave. As part of this process, collaborative planning techniques were used to develop the intervention. A planning group was set up, through which researchers would work alongside employer, worker, and mental health professional representatives to develop the toolkits. Additionally, feedback on the toolkits were sought from the target populations of workers and managers and from wider employer stakeholders (e.g., human resource specialists). The implementation and evaluation of the toolkits as a workplace intervention were also planned. RESULTS: Two toolkits were designed following the six steps of intervention mapping. Feedback from the planning group (n = 5; psychologist, psychiatrist, person with previous experience of poor mental health, employer and charity worker) and participants (n = 14; employers = 3, wellbeing director = 1; human resources = 2, managers = 2, employees with previous experience of poor mental health = 5) target populations indicated that the toolkits were acceptable and much needed. CONCLUSIONS: Using IM allowed the development of an evidence-based practical intervention, whilst incorporating the views of all the impacted stakeholder groups. The feasibility and acceptability of the toolkits and their supporting intervention components, implementation process and methods of assessment will be evaluated in a feasibility pilot randomised controlled trial.

Sleep Variability in UK Long Distance Heavy Goods Vehicle Drivers.

OBJECTIVES: Sleep variability levels are unknown in heavy goods vehicle (HGV) drivers yet are associated with adverse health outcomes and reduced driver vigilance when high. METHODS: Two hundred and thirty-three HGV drivers recruited across 25 UK depots provided sleep variability, sleep duration, and sleep efficiency data via wrist-worn accelerometry (GENEActiv) over 8 days. Sleep variability indicators included social jetlag (the difference in midpoint of the sleep window between work and nonworkdays) and intraindividual variability of sleep window onset time, out-of-bed time, and sleep duration. RESULTS: Fifty-three percent of drivers experienced social jetlag (≥1 hour), and 27% experienced high (>2 hours) social jetlag. Drivers with the highest sleep variability had the shortest sleep duration and lowest sleep efficiency during workdays. CONCLUSIONS: Drivers with high sleep variability may experience more fatigue when driving given the poor sleep outcomes during workdays observed.

Attenuated Cardiovascular Reactivity to Acute Psychological Stress Predicts Future Fatigue Symptoms in Truck Drivers.

OBJECTIVES: This study aimed to investigate the impact of a 6-month health intervention on truck drivers' cardiovascular reactivity to stress and whether cardiovascular reactivity was predictive of depression, anxiety, or fatigue symptoms at 6-month follow-up. METHODS: Two hundred thirty-eight truck drivers completed a 6-month cluster randomized controlled trial to increase physical activity and completed a stress protocol (Stroop and mirror-tracing tasks) with measurements of heart rate, systolic blood pressure, and diastolic blood pressure taken, alongside fatigue, anxiety, and depressive symptoms assessment. Measures were taken at 0 and 6 months. RESULTS: Analyses showed a negative relationship between 0-month diastolic blood pressure reactivity and 6-month persistent fatigue. Trends toward negative relationships between systolic blood pressure reactivity and future anxiety and fatigue symptoms at 6 months were evident. CONCLUSIONS: Our findings may have serious implications, as fatigue can be a major cause of road traffic collisions in truck drivers.

Drivers with and without Obesity Respond Differently to a Multi-Component Health Intervention in Heavy Goods Vehicle Drivers.

Physical inactivity and obesity are widely prevalent in Heavy Goods Vehicle (HGV) drivers. We analysed whether obesity classification influenced the effectiveness of a bespoke structured lifestyle intervention ('SHIFT') for HGV drivers. The SHIFT programme was evaluated within a cluster randomised controlled trial, across 25 transport depots in the UK. After baseline assessments, participants within intervention sites received a 6-month multi-component health behaviour change intervention. Intervention responses (verses control) were stratified by obesity status (BMI < 30 kg/m2, n = 131; BMI ≥ 30 kg/m2, n = 113) and compared using generalised estimating equations. At 6-months, favourable differences were found in daily steps (adjusted mean difference 1827 steps/day, p < 0.001) and sedentary time (adjusted mean difference -57 min/day, p < 0.001) in drivers with obesity undertaking the intervention, relative to controls with obesity. Similarly, in drivers with obesity, the intervention reduced body weight (adjusted mean difference -2.37 kg, p = 0.002) and led to other favourable anthropometric outcomes, verses controls with obesity. Intervention effects were absent for drivers without obesity, and for all drivers at 16-18-months follow-up. Obesity classification influenced HGV drivers' behavioural responses to a multi-component health-behaviour change intervention. Therefore, the most at-risk commercial drivers appear receptive to a health promotion programme.

Protocol for a feasibility randomised controlled study of a multicomponent intervention to promote a sustainable return to work of workers on long-term sick leave - PROWORK: PROmoting a Sustainable and Healthy Return to WORK.

BACKGROUND: The cost of sickness absence has major social, psychological and financial implications for individuals and organisations. Return-to-work (RTW) interventions that support good quality communication and contact with the workplace can reduce the length of sickness absence by between 15 and 30 days. However, initiatives promoting a sustainable return to work for workers with poor mental health on long-term sickness absence across small, medium and large enterprises (SMEs and LEs) are limited. This paper describes the protocol of a pilot randomised controlled trial (RCT) to test the feasibility of implementing a RTW intervention across SMEs and LEs across all sectors. METHODS AND DESIGN: A two-arm feasibility RCT with a 4-month intervention will be conducted in SMEs and LE enterprises from the Midlands region, UK. At least 8 organisations (4 controls and interventions), and at least 60 workers and/or managers, will be recruited and randomised into the intervention and control group (30 interventions, 30 controls). Workers on long-term sickness absence (LTSA) (between 8 and 50 days) and managers with a worker on LTSA will be eligible to participate. The intervention is a behavioural change programme, including a managers and workers RTW toolkit, focused on supporting sickness absence and RTW through the provision of knowledge, problem-solving, action planning, goal setting and positive communication that leads to a sustainable RTW. Organisations assigned to the control group will continue with their usual practice. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 2 months and 4 months. Feasibility will be assessed based on recruitment, retention, attrition, completion of measures and intervention compliance for which specific process and research outcomes have been established. A process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial. DISCUSSION: This is a novel intervention using a worker-manager approach to promote a sustainable return to work of workers on long-term sick leave due to poor mental wellbeing. If this intervention is shown to be feasible, the outcomes will inform a larger scale randomised control trial. TRIAL REGISTRATION: ISRCTN90032009 (retrospectively registered, date registered 15th December 2020).

The structured health intervention for truckers (SHIFT) cluster randomised controlled trial: a mixed methods process evaluation.

BACKGROUND: This paper presents the mixed methods process evaluation of the randomised controlled trial (RCT) of the Structured Health Intervention For Truckers (SHIFT), a multi-component intervention targeting physical activity and positive lifestyle behaviours in a cohort of 382 truck drivers in the UK. The SHIFT RCT found a significant difference in daily steps between intervention and control groups at 6-months in favour of the intervention participants. METHODS: SHIFT was evaluated within a cluster-RCT and involved 25 transport sites (12 intervention and 13 control sites). Intervention components included an education session, Fitbit, text messages, and cab workout equipment. Participants completed questionnaires at baseline and 6-months follow-up. Semi-structured focus groups/interviews were conducted with drivers (n = 19) and managers (n = 18) from each site, after completion of the final follow-up health assessment (16-18 months post-randomisation). Questionnaires and interviews collected information on fidelity, dose, context, implementation, barriers, sustainability, and contamination. RESULTS: Questionnaire and interview data from intervention participants indicated favourable attitudes towards SHIFT, specifically towards the Fitbit with a high proportion of drivers reporting regularly using it (89.1%). 79.2% of intervention participants attended the education session, which was deemed useful for facilitating improvements in knowledge and behaviour change, dietary changes were predominantly recalled. Despite not being part of the intervention, participants reported that feedback from the health assessments motivated them to change aspects of their lifestyle (intervention = 91.1%, control = 67.5%). The cab workout equipment was used less and spoken unfavourably of in the interviews. The main barriers to a healthy lifestyle at work were reported as long hours and irregular shift patterns. The most suggested improvement for the intervention was more frequent contact with drivers. Managers were positive about the objectives of SHIFT, however almost all mentioned the challenges related to implementation, specifically in smaller sites. CONCLUSIONS: Overall, SHIFT was predominantly implemented as intended, with minimal discrepancies seen between the delivery and protocol. Having said this, transport sites each have distinct characteristics, which may require adaptations to individual settings to encourage participation. Managers and drivers reported enthusiasm and necessity for SHIFT to be included in future Certificate of Professional Competence training. TRIAL REGISTRATION: ISRCTN10483894 (date registered: 01/03/2017).

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

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).

Physical Activity, Sedentary Time, and Cardiometabolic Health in Heavy Goods Vehicle Drivers.

OBJECTIVE: Physical inactivity, prolonged sitting, and unhealthy dietary habits are common in Heavy Goods Vehicle (HGV) drivers. These factors increase risk of long-term health conditions. METHODS: 329 HGV drivers across 25 UK depots completed a health assessment, including questionnaire completion, and objectively measured anthropometrics, blood biomarkers, physical activity (PA), and sedentary behavior. RESULTS: The sample demonstrated a high-risk cardiometabolic health profile. 88.1% were overweight or had obesity, and 11.9% had pre-diabetes or diabetes. 28.3% had hypertension, 83.6% had clinically elevated circulating low-density lipoprotein-cholesterol concentrations (>2mmol/l), and 66.6% had high total cholesterol levels (>4mmol/l). On workdays drivers accumulated 12 hours/day of sitting, 1.7 hours/day of light PA, and 9.8 mins/day of moderate-to-vigorous PA. Associations between light PA and cardiometabolic markers were observed. CONCLUSION: This sample presents high levels of inactivity, overweight, and obesity, and unhealthy cardiometabolic health profiles.

Sleep duration and sleep efficiency in UK long-distance heavy goods vehicle drivers.

OBJECTIVES: To profile sleep duration and sleep efficiency in UK long-distance heavy goods vehicle (HGV) drivers and explore demographic, occupational and lifestyle predictors of sleep. METHODS: Cross-sectional analyses were carried out on 329 HGV drivers (98.5% men) recruited across an international logistics company within the midland's region, UK. Sleep duration and efficiency were assessed via wrist-worn accelerometry (GENEActiv) over 8 days. Proportions of drivers with short sleep duration (<6 hour/24 hours and <7 hour/24 hours) and inadequate sleep efficiency (<85%) were calculated. Demographic, occupational and lifestyle data were collected via questionnaires and device-based measures. Logistic regression assessed predictors of short sleep duration and inadequate sleep efficiency. RESULTS: 58% of drivers had a mean sleep duration of <6 hour/24 hours, 91% demonstrated <7-hour sleep/24 hours and 72% achieved <85% sleep efficiency. Sleeping <6 hour/24 hours was less likely in morning (OR 0.45, 95% CI 0.21 to 0.94) and afternoon (OR 0.24, CI 0.10 to 0.60) shift workers (vs night) and if never smoked (vs current smokers) (OR 0.45, CI -0.22 to 0.92). The likelihood of sleeping <7 hour/24 hours reduced with age (OR 0.92, CI 0.87 to 0.98). The likelihood of presenting inadequate sleep efficiency reduced with age (OR 0.96, CI 0.93 to 0.99) and overweight body mass index category (vs obese) (OR 0.47, CI 0.27 to 0.82). CONCLUSIONS: The high prevalence of short sleep duration and insufficient sleep quality (efficiency) rate suggest that many HGV drivers have increased risk of excessive daytime sleepiness, road traffic accidents and chronic disease. Future sleep research in UK HGV cohorts is warranted given the road safety and public health implications.

Corrigendum: Elena+ Care for COVID-19, a Pandemic Lifestyle Care Intervention: Intervention Design and Study Protocol.

[This corrects the article DOI: 10.3389/fpubh.2021.625640.].

Evaluation of a natural workspace intervention with active design features on movement, interaction and health.

BACKGROUND: There is increasing focus on designing workspaces that promote less sitting, more movement and interaction to improve physical and mental health. OBJECTIVE: This study evaluates a natural intervention of a new workplace with active design features and its relocation to a greener and open space. METHODS: An ecological model was used to understand how organisations implement change. Pre and post survey data from 221 matched cases of workers and accelerometery data (n = 50) were analysed. RESULTS: Results show a decrease in occupational sitting (-20.65 mins/workday, p = 0.001) and an increase in workplace walking (+5.61 mins/workday, p = 0.001) using survey data, and accelerometery data (occupational sitting time: -31.0 mins/workday, p = 0.035, standing time: +22.0 mins/workday, p = 0.022, stepping time: +11.0 mins/workday, p = 0.001). Improvements in interaction, musculoskeletal pain and mental health were reported. CONCLUSIONS: Application of the ecological model shows that the organisation understands how to target the built environment and social/cultural environment but not how to target behaviour change at the individual level.

Elena+ Care for COVID-19, a Pandemic Lifestyle Care Intervention: Intervention Design and Study Protocol.

Background: The current COVID-19 coronavirus pandemic is an emergency on a global scale, with huge swathes of the population required to remain indoors for prolonged periods to tackle the virus. In this new context, individuals' health-promoting routines are under greater strain, contributing to poorer mental and physical health. Additionally, individuals are required to keep up to date with latest health guidelines about the virus, which may be confusing in an age of social-media disinformation and shifting guidelines. To tackle these factors, we developed Elena+, a smartphone-based and conversational agent (CA) delivered pandemic lifestyle care intervention. Methods: Elena+ utilizes varied intervention components to deliver a psychoeducation-focused coaching program on the topics of: COVID-19 information, physical activity, mental health (anxiety, loneliness, mental resources), sleep and diet and nutrition. Over 43 subtopics, a CA guides individuals through content and tracks progress over time, such as changes in health outcome assessments per topic, alongside user-set behavioral intentions and user-reported actual behaviors. Ratings of the usage experience, social demographics and the user profile are also captured. Elena+ is available for public download on iOS and Android devices in English, European Spanish and Latin American Spanish with future languages and launch countries planned, and no limits on planned recruitment. Panel data methods will be used to track user progress over time in subsequent analyses. The Elena+ intervention is open-source under the Apache 2 license (MobileCoach software) and the Creative Commons 4.0 license CC BY-NC-SA (intervention logic and content), allowing future collaborations; such as cultural adaptions, integration of new sensor-related features or the development of new topics. Discussion: Digital health applications offer a low-cost and scalable route to meet challenges to public health. As Elena+ was developed by an international and interdisciplinary team in a short time frame to meet the COVID-19 pandemic, empirical data are required to discern how effective such solutions can be in meeting real world, emergent health crises. Additionally, clustering Elena+ users based on characteristics and usage behaviors could help public health practitioners understand how population-level digital health interventions can reach at-risk and sub-populations.

Attenuated cardiovascular reactivity is related to higher anxiety and fatigue symptoms in truck drivers.

Depression and anxiety have been linked with reduced stress-induced cardiovascular reactivity (CVR), which could be indicative of autonomic dysregulation. Less is known about the association between work-related fatigue and CVR. Truck drivers experience high levels of depression, anxiety, and fatigue, with repeated psychophysiological stressors on the road, yet little is known about the effects of these conditions on their CVR. Three hundred eighty six truck drivers completed the Hospital Anxiety and Depression Scale (HADS) and the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Systolic (SBP) and diastolic (DBP) blood pressure and heart rate (HR) were measured at rest and during a stressor protocol to measure CVR. Multivariate regression analyses were used to determine relationships between variables and adjusted for nine key covariates. Higher symptoms of persistent fatigue were related to a reduced SBP reactivity (ß = -.236, p = .009) and reduced DBP reactivity (ß = -.257, p = .005), whereas there was a positive trend between acute fatigue and DBP reactivity (ß = .169, p = .052). Higher symptoms of anxiety were related to a reduced SBP reactivity (ß = -.164, p = .016). This study demonstrated in a population of truck drivers that both anxiety and persistent fatigue were related to an attenuated SBP reactivity in a combined model, whereas there was a positive trend between acute fatigue solely and DBP reactivity. These novel findings may have serious implications for cardiovascular disease risk in truck drivers, and future research should attempt to establish the causal effect of these associations and the underlying physiological mechanisms.

Time in Nature Associated with Decreased Fatigue in UK Truck Drivers.

Heavy goods vehicle (HGV) driving is recognised as a highly hazardous occupation due to the long periods of sedentary behaviour, low levels of physical activity and unhealthy food options when working. These risk factors combine with shift work and concomitant irregular sleep patterns to increase the prevalence of fatigue. Fatigue is closely linked with stress and, subsequently, poor physiological and psychological health. In parallel, a wealth of evidence has demonstrated the health and wellbeing benefits of spending time in nature. Here, we sought to examine whether spending time in nature was associated with lower levels of fatigue, anxiety and depression in HGV drivers. 89 long-distance drivers (98.9% male, mean ± SD age: 51.0 ± 9 years, body mass index: 29.8 ± 4.7 kg/m2) participating in a wider health promotion programme reported time spent in nature (during and before the Covid-19 pandemic) and symptoms of occupational fatigue, depression and anxiety. After controlling for covariates, truck drivers who visited nature at least once a week exhibited 16% less chronic fatigue prior to the pandemic, and 23% less chronic fatigue and 20% less acute fatigue during the pandemic. No significant differences were observed for either anxiety or depression. As fatigue has a range of physical and mental health sequelae, we propose that increased exposure to natural settings may make a valuable contribution to interventions to promote the health and wellbeing of this underserved group.

Targeting body composition in an older population: do changes in movement behaviours matter? Longitudinal analyses in the PREDIMED-Plus trial.

BACKGROUND: The optimal distribution between physical activity (PA) levels and sedentary behaviour (SB) for the greatest benefits for body composition among older adults with overweight/obesity and chronic health conditions remains unclear. We aimed to determine the prospective association between changes in PA and in SB with concurrent changes in body composition and to examine whether reallocating inactive time into different physical activity levels was associated with 12-month change to body composition in older adults. METHODS: Longitudinal assessment nested in the PREDIMED-Plus trial. A subsample (n = 1564) of men and women (age 55-75 years) with overweight/obesity and metabolic syndrome from both arms of the PREDIMED-Plus trial was included in the present analysis. Participants were followed up at 6 and 12 months. Physical activity and SB were assessed using validated questionnaires. Out of 1564 participants, 388 wore an accelerometer to objectively measure inactive time and PA over a 7-day period. At each time point, participants' body composition was measured using dual-energy X-ray absorptiometry (DXA). Standard covariate-adjusted and isotemporal substitution modelling were applied to linear mixed-effects models. RESULTS: Increasing 30 min of total PA and moderate-to-vigorous physical activity (MVPA) was associated with significant reductions in body fat (ß - 0.07% and - 0.08%) and visceral adipose tissue (VAT) (- 13.9 g, and - 15.6 g) at 12 months (all p values < 0.001). Reallocating 30 min of inactive time to MVPA was associated with reductions in body fat and VAT and with an increase in muscle mass and muscle-to-fat mass ratio (all p values < 0.001). CONCLUSIONS: At 12 months, increasing total PA and MVPA and reducing total SB and TV-viewing SB were associated with improved body composition in participants with overweight or obesity, and metabolic syndrome. This was also observed when substituting 30 min of inactive time with total PA, LPA and MVPA, with the greatest benefits observed with MVPA. TRIAL REGISTRATION: International Standard Randomized Controlled Trial (ISRCTN), 89898870 . Retrospectively registered on 24 July 2014.

Acute Hyperenergetic, High-Fat Feeding Increases Circulating FGF21, LECT2, and Fetuin-A in Healthy Men.

BACKGROUND: Hepatokines such as fibroblast growth factor 21 (FGF21), leukocyte cell-derived chemotaxin 2 (LECT2), fetuin-A, fetuin-B, and selenoprotein P (SeP) are liver-derived proteins that are modulated by chronic energy status and metabolic disease. Emerging data from rodent and cell models indicate that hepatokines may be sensitive to acute nutritional manipulation; however, data in humans are lacking. OBJECTIVE: The aim was to investigate the influence of hyperenergetic, high-fat feeding on circulating hepatokine concentrations, including the time course of responses. METHODS: In a randomized, crossover design, 12 healthy men [mean ± SD: age, 24 ± 4 y; BMI (kg/m2), 24.1 ± 1.5] consumed a 7-d hyperenergetic, high-fat diet [HE-HFD; +50% energy, 65% total energy as fat (32% saturated, 26% monounsaturated, 8% polyunsaturated)] and control diet (36% total energy as fat), separated by 3 wk. Whole-body insulin sensitivity was assessed before and after each diet using oral-glucose-tolerance tests. Fasting plasma concentrations of FGF21 (primary outcome), LECT2, fetuin-A, fetuin-B, SeP, and related metabolites were measured after 1, 3, and 7 d of each diet. Hepatokine responses were analyzed using 2-factor repeated-measures ANOVA and subsequent pairwise comparisons. RESULTS: Compared with the control, the HE-HFD increased circulating FGF21 at 1 d (105%) and 3 d (121%; P ≤ 0.040), LECT2 at 3 d (17%) and 7 d (32%; P ≤ 0.004), and fetuin-A at 7 d (7%; P = 0.028). Plasma fetuin-B and SeP did not respond to the HE-HFD. Whole-body insulin sensitivity was reduced after the HE-HFD by 31% (P = 0.021). CONCLUSIONS: Acute high-fat overfeeding augments circulating concentrations of FGF21, LECT2, and fetuin-A in healthy men. Notably, the time course of response varies between proteins and is transient for FGF21. These findings provide further insight into the nutritional regulation of hepatokines in humans and their interaction with metabolic homeostasis. This study was registered at clinicaltrials.gov as NCT03369145.

Isotemporal substitution of inactive time with physical activity and time in bed: cross-sectional associations with cardiometabolic health in the PREDIMED-Plus study.

BACKGROUND: This study explored the association between inactive time and measures of adiposity, clinical parameters, obesity, type 2 diabetes and metabolic syndrome components. It further examined the impact of reallocating inactive time to time in bed, light physical activity (LPA) or moderate-to-vigorous physical activity (MVPA) on cardio-metabolic risk factors, including measures of adiposity and body composition, biochemical parameters and blood pressure in older adults. METHODS: This is a cross-sectional analysis of baseline data from 2189 Caucasian men and women (age 55-75 years, BMI 27-40 Kg/m2) from the PREDIMED-Plus study (http://www.predimedplus.com/). All participants had ≥3 components of the metabolic syndrome. Inactive time, physical activity and time in bed were objectively determined using triaxial accelerometers GENEActiv during 7 days (ActivInsights Ltd., Kimbolton, United Kingdom). Multiple adjusted linear and logistic regression models were used. Isotemporal substitution regression modelling was performed to assess the relationship of replacing the amount of time spent in one activity for another, on each outcome, including measures of adiposity and body composition, biochemical parameters and blood pressure in older adults. RESULTS: Inactive time was associated with indicators of obesity and the metabolic syndrome. Reallocating 30 min per day of inactive time to 30 min per day of time in bed was associated with lower BMI, waist circumference and glycated hemoglobin (HbA1c) (all p-values < 0.05). Reallocating 30 min per day of inactive time with 30 min per day of LPA or MVPA was associated with lower BMI, waist circumference, total fat, visceral adipose tissue, HbA1c, glucose, triglycerides, and higher body muscle mass and HDL cholesterol (all p-values < 0.05). CONCLUSIONS: Inactive time was associated with a poor cardio-metabolic profile. Isotemporal substitution of inactive time with MVPA and LPA or time in bed could have beneficial impact on cardio-metabolic health. TRIAL REGISTRATION: The trial was registered at the International Standard Randomized Controlled Trial (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.

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

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.

Exploration of associations between the FTO rs9939609 genotype, fasting and postprandial appetite-related hormones and perceived appetite in healthy men and women.

BACKGROUND: The fat mass and obesity-associated gene (FTO) rs9939609 A-allele has been associated with obesity risk. Although the exact mechanisms involved remain unknown, the FTO rs9939609 A-allele has been associated with an impaired postprandial suppression of appetite. OBJECTIVES: To explore the influence of FTO rs9939609 genotype on fasting and postprandial appetite-related hormones and perceived appetite in a heterogeneous sample of men and women. DESIGN: 112 healthy men and women aged 18-50-years-old completed three laboratory visits for the assessment of FTO rs9939609 genotype, body composition, aerobic fitness, resting metabolic rate, visceral adipose tissue, liver fat, fasting leptin, and fasting and postprandial acylated ghrelin, total PYY, insulin, glucose and perceived appetite. Participants wore accelerometers for seven consecutive days for the assessment of physical activity and sedentary behaviour. Multivariable general linear models quantified differences between FTO rs9939609 groups for fasting and postprandial appetite outcomes, with and without the addition of a priori selected physiological and behavioural covariates. Sex-specific univariable Pearson's correlation coefficients were quantified between the appetite-related outcomes and individual characteristics. RESULTS: 95% confidence intervals for mean differences between FTO rs9939609 groups overlapped zero in unadjusted and adjusted general linear models for all fasting (P ≥ 0.28) and postprandial (P ≥ 0.19) appetite-related outcomes. Eta2 values for explained variance attributable to FTO rs9939609 were <5% for all outcomes. An exploratory correlation matrix indicated that associations between fasting and postprandial acylated ghrelin, total PYY and general or abdominal adiposity were also small (r = -0.23 to 0.15, P ≥ 0.09). Fasting leptin, glucose and insulin and postprandial insulin concentrations were associated with adiposity outcomes (r = 0.29 to 0.81, P ≤ 0.033). CONCLUSIONS: Associations between the FTO rs9939609 genotype and fasting or postprandial appetite-related outcomes were weak in healthy men and women.