A support package for parents of excessively crying infants: development and feasibility study.

BACKGROUND: Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder ('colic'), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents. Parental vulnerabilities influence how parents evaluate and respond to the crying and predict adverse outcomes. By developing evidence-based services that support parents, this study was designed to take the first steps towards national health services that enhance the coping and well-being of parents whose babies excessively cry. Related aims were to improve these infants' outcomes and how NHS money is spent. OBJECTIVES: To develop a novel intervention package to support parents of excessively crying infants and to examine the feasibility of delivering and evaluating it in the NHS. DESIGN: Stage 1 of this study aimed to (1) complete a literature review to identify example support materials, (2) obtain parents' guidance on the support needed when a baby cries excessively, together with their evaluation of the example materials, and (3) develop a support package based on the results. Stage 2 aimed to (1) recruit 60 parents whose babies were currently excessively crying, (2) assess parents' and NHS professionals' willingness to complete a study of the support package, (3) measure the use and evaluation of the package components, (4) estimate the package component costs and (5) provide evidence on the feasibility and methods for a large-scale trial. SETTING: Primary health care. PARTICIPANTS: Stage 1: 20 parents of previously excessively crying infants and 55 health visitors (HVs) or specialist community public health nurses (SCPHNs). Stage 2: 57 parents of currently excessively crying infants and 124 HVs/SCPHNs. INTERVENTIONS: The support package included a website, a printed booklet and a programme of cognitive-behavioural therapy-based sessions delivered to parents by a qualified practitioner. MAIN OUTCOME MEASURES: (1) Demographic data, (2) figures for parents' use of the package components and continuation in the study, (3) parents' and HVs'/SCPHNs' ratings of the package components and suitability for NHS use, (4) questionnaire measures of parental well-being and infant health and (5) costs. RESULTS: Most parents (95%) accessed the website or printed materials and half (51%) attended the practitioner sessions. All 52 parents and 85% of HVs/SCPHNs providing data would support the inclusion of the package in the NHS. It was associated with reduced parental frustration, anxiety, depression, reported infant crying and contacts with health professionals and increased knowledge about crying. Methods for a full trial and figures for the cost of excessive infant crying for the NHS and each package element were identified. LIMITATIONS: No control group was included. Most of the recruited parents were white, well educated and in stable relationships. CONCLUSIONS: Parents and HVs/SCPHNs recognise the need for NHS provisions that support parents of excessively crying babies and consider the materials developed to meet that need. A full-scale randomised controlled trial is feasible and desirable. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84975637. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 56. See the NIHR Journals Library website for further project information

A multicomponent intervention to reduce daily sitting time in office workers: the SMART Work & Life three-arm cluster RCT

Background: Office workers spend 70–85% of their time at work sitting. High levels of sitting have been linked to poor physiological and psychological health. Evidence shows the need for fully powered randomised controlled trials, with long-term follow-up, to test the effectiveness of interventions to reduce sitting time. Objective: Our objective was to test the clinical effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable workstation, compared with usual practice at 12-month follow-up. Design: A three-arm cluster randomised controlled trial. Setting: Councils in England. Participants: Office workers. Intervention: SMART Work & Life is a multicomponent intervention that includes behaviour change strategies, delivered by workplace champions. Clusters were randomised to (1) the SMART Work & Life intervention, (2) the SMART Work & Life intervention with a height-adjustable workstation (i.e. SMART Work & Life plus desk) or (3) a control group (i.e. usual practice). Outcome measures were assessed at baseline and at 3 and 12 months. Main outcome measures: The primary outcome was device-assessed daily sitting time compared with usual practice at 12 months. Secondary outcomes included sitting, standing, stepping time, physical activity, adiposity, blood pressure, biochemical measures, musculoskeletal issues, psychosocial variables, work-related health, diet and sleep. Cost-effectiveness and process evaluation data were collected. Results: A total of 78 clusters (756 participants) were randomised [control, 26 clusters (n = 267); SMART Work & Life only, 27 clusters (n = 249); SMART Work & Life plus desk, 25 clusters (n = 240)]. At 12 months, significant differences between groups were found in daily sitting time, with participants in the SMART Work & Life-only and SMART Work & Life plus desk arms sitting 22.2 minutes per day (97.5% confidence interval –38.8 to –5.7 minutes/day; p = 0.003) and 63.7 minutes per day (97.5% confidence interval –80.0 to –47.4 minutes/day; p < 0.001), respectively, less than the control group. Participants in the SMART Work & Life plus desk arm sat 41.7 minutes per day (95% confidence interval –56.3 to –27.0 minutes/day; p < 0.001) less than participants in the SMART Work & Life-only arm. Sitting time was largely replaced by standing time, and changes in daily behaviour were driven by changes during work hours on workdays. Behaviour changes observed at 12 months were similar to 3 months. At 12 months, small improvements were seen for stress, well-being and vigour in both intervention groups, and for pain in the lower extremity and social norms in the SMART Work & Life plus desk group. Results from the process evaluation supported these findings, with participants reporting feeling more energised, alert, focused and productive. The process evaluation also showed that participants viewed the intervention positively; however, the extent of engagement varied across clusters. The average cost of SMART Work & Life only and SMART Work & Life plus desk was £80.59 and £228.31 per participant, respectively. Within trial, SMART Work & Life only had an incremental cost-effectiveness ratio of £12,091 per quality-adjusted life-year, with SMART Work & Life plus desk being dominated. Over a lifetime, SMART Work & Life only and SMART Work & Life plus desk had incremental cost-effectiveness ratios of £4985 and £13,378 per quality-adjusted life-year, respectively. Limitations: The study was carried out in one sector, limiting generalisability. Conclusions: The SMART Work & Life intervention, provided with and without a height-adjustable workstation, was successful in changing sitting time. Future work: There is a need for longer-term follow-up, as well as follow-up within different organisations. Trial registration: Current Controlled Trials ISRCTN11618007

Rationale and methods for the Exercise for Type 1 Diabetes Education program: a pilot randomized controlled trial of an education program to support adults with type 1 diabetes mellitus (T1DM) to undertake exercise

Objective Regular exercise in people with type 1 diabetes mellitus (T1DM) can result in considerable improvements in health and reduction in cardiovascular events and death. However, a large proportion of people with T1DM are not active. Fear of hypoglycemia and lack of knowledge on how to manage their diabetes are major barriers to exercise in people with T1DM, but few patients receive specific advice about how to adjust insulin and carbohydrate for activity. Furthermore, healthcare professionals (HCP) currently lack the knowledge to advise patients on how to manage their diabetes when active and would like formal training in exercise prescription for people with T1DM. Research design and methods This study is divided into two stages. The first stage develops an education program aimed to support people with T1DM to exercise using the Medical Research Council framework. The second stage is a pilot randomized controlled trial (RCT) that aims to collect the key variables to design a definitive trial to test the efficacy and cost-effectiveness of the education package. We aim to recruit 96 patients with T1DM at two UK hospitals. Conclusions This article outlines the protocol for a pilot RCT to develop a program of education that will support adults with T1DM to undertake safe and effective exercise. This is accompanied by training for HCPs to deliver this educational intervention. Successful completion of this program of work will address some of the barriers to exercise in adults with T1DM, and should facilitate an increase in exercise for this group of people.Trial registration number ISRCTN61403534

Sit-stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT

Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.<br

Additional file 2: of Stand Out in Class: restructuring the classroom environment to reduce sedentary behaviour in 9–10-year-olds — study protocol for a pilot cluster randomised controlled trial

SPIRIT checklist. (DOCX 51 kb

Effectiveness of an intervention for reducing sitting time and improving health in office workers: three arm cluster randomised controlled trial

Objectives: To 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.  Design: Cluster three arm randomised controlled trial with follow-up at three and 12 months.  Setting: Local government councils in Leicester, Liverpool, and Greater Manchester, UK.  Participants: 78 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.  Interventions: Clusters 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 measures: The 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.  Results: Mean 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 Conclusions: Both 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 registration: ISRCTN Registry ISRCTN11618007.</p

Stand Out in Class: restructuring the classroom environment to reduce sitting time - findings from a pilot cluster randomised controlled trial

Background: Excessive sedentary behaviour (sitting) is a risk factor for poor health in children and adults. Incorporating sit-stand desks in the classroom environment has been highlighted as a potential strategy to reduce children's sitting time. The primary aim of this study was to examine the feasibility of conducting a cluster randomised controlled trial (RCT) of a sit-stand desk intervention within primary school classrooms. Methods: We conducted a two-armed pilot cluster RCT involving 8 primary schools in Bradford, United Kingdom. Schools were randomised on a 1:1 basis to the intervention or usual practice control arm. All children (aged 9-10 years) in participating classes were eligible to take part. Six sit-stand desks replaced three standard desks (sitting 6 children) in the intervention classrooms for 4.5-months. Teachers were encouraged to use a rotation system to ensure all pupils were exposed to the sit-stand desks for > 1 h/day on average. Trial feasibility outcomes (assessed using quantitative and qualitative measures) included school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time. A weighted linear regression model compared changes in weekday sitting time (assessed using the activPAL accelerometer) between trial arms. Results: School and child recruitment rates were 33% (n = 8) and 75% (n = 176). At follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63 to 97%. A preliminary estimate of intervention effectiveness revealed a mean difference in change in sitting of - 30.6 min/day (95% CI: - 56.42 to - 4.84) in favour of the intervention group, after adjusting for baseline sitting and wear time. Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment. Conclusion: This study provides evidence of the acceptability and feasibility of a sit-stand desk intervention and evaluation methods. Preliminary evidence suggests the intervention showed potential in reducing children's weekday sitting but some adaptations to the desk rotation system are needed to maximize exposure. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration: ISRCTN12915848 (registered: 09/11/16)

A multicomponent intervention to reduce daily sitting time in office workers: the SMART Work & Life three-arm cluster RCT

Background Office workers spend 70–85% of their time at work sitting. High levels of sitting have been linked to poor physiological and psychological health. Evidence shows the need for fully powered randomised controlled trials, with long-term follow-up, to test the effectiveness of interventions to reduce sitting time. Objective Our objective was to test the clinical effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable workstation, compared with usual practice at 12-month follow-up. Design A three-arm cluster randomised controlled trial. Setting Councils in England. Participants Office workers. Intervention SMART Work & Life is a multicomponent intervention that includes behaviour change strategies, delivered by workplace champions. Clusters were randomised to (1) the SMART Work & Life intervention, (2) the SMART Work & Life intervention with a height-adjustable workstation (i.e. SMART Work & Life plus desk) or (3) a control group (i.e. usual practice). Outcome measures were assessed at baseline and at 3 and 12 months. Main outcome measures The primary outcome was device-assessed daily sitting time compared with usual practice at 12 months. Secondary outcomes included sitting, standing, stepping time, physical activity, adiposity, blood pressure, biochemical measures, musculoskeletal issues, psychosocial variables, work-related health, diet and sleep. Cost-effectiveness and process evaluation data were collected. Results A total of 78 clusters (756 participants) were randomised [control, 26 clusters (n = 267); SMART Work & Life only, 27 clusters (n = 249); SMART Work & Life plus desk, 25 clusters (n = 240)]. At 12 months, significant differences between groups were found in daily sitting time, with participants in the SMART Work & Life-only and SMART Work & Life plus desk arms sitting 22.2 minutes per day (97.5% confidence interval –38.8 to –5.7 minutes/day; p = 0.003) and 63.7 minutes per day (97.5% confidence interval –80.0 to –47.4 minutes/day; p < 0.001), respectively, less than the control group. Participants in the SMART Work & Life plus desk arm sat 41.7 minutes per day (95% confidence interval –56.3 to –27.0 minutes/day; p < 0.001) less than participants in the SMART Work & Life-only arm. Sitting time was largely replaced by standing time, and changes in daily behaviour were driven by changes during work hours on workdays. Behaviour changes observed at 12 months were similar to 3 months. At 12 months, small improvements were seen for stress, well-being and vigour in both intervention groups, and for pain in the lower extremity and social norms in the SMART Work & Life plus desk group. Results from the process evaluation supported these findings, with participants reporting feeling more energised, alert, focused and productive. The process evaluation also showed that participants viewed the intervention positively; however, the extent of engagement varied across clusters. The average cost of SMART Work & Life only and SMART Work & Life plus desk was £80.59 and £228.31 per participant, respectively. Within trial, SMART Work & Life only had an incremental cost-effectiveness ratio of £12,091 per quality-adjusted life-year, with SMART Work & Life plus desk being dominated. Over a lifetime, SMART Work & Life only and SMART Work & Life plus desk had incremental cost-effectiveness ratios of £4985 and £13,378 per quality-adjusted life-year, respectively. Limitations The study was carried out in one sector, limiting generalisability. Conclusions The SMART Work & Life intervention, provided with and without a height-adjustable workstation, was successful in changing sitting time. Future work There is a need for longer-term follow-up, as well as follow-up within different organisations. Trial registration Current Controlled Trials ISRCTN11618007. Plain language summary Office workers spend a large proportion of their day sitting. High levels of sitting have been linked to diseases, such as type 2 diabetes, heart disease and some cancers. The SMART Work & Life intervention is designed to reduce office workers’ sitting time inside and outside work. The SMART Work & Life intervention involves organisational, environmental, group and individual strategies to encourage a reduction in sitting time and was designed to be delivered with and without a height-adjustable workstation (which allows the user to switch between sitting and standing while working). To test whether or not the SMART Work & Life intervention worked, we recruited 756 office workers from councils in Leicester/Leicestershire, Greater Manchester and Liverpool, UK. Participants were from 78 office groups. One-third of the participants received the intervention, one-third received the intervention with a height-adjustable workstation and one-third were a control group (and carried on as usual). Workplace champions in each office group were given training and resources to deliver the intervention. Data were collected at the start of the study, with follow-up measurements at 3 and 12 months. We measured sitting time using a small device worn on the thigh and collected data on weight, body fat, blood pressure, blood sugar and cholesterol levels. We asked participants about their health and work and spoke to participants to find out what they thought of the intervention. Our results showed that participants who received the intervention without workstation sat for 22 minutes less per day, and participants who received the intervention with workstation sat for 64 minutes less per day, than participants in the control group. Levels of stress, well-being, vigour (i.e. personal and emotional energy and cognitive liveliness) and pain in the lower extremity appeared to improve in the intervention groups. Participants viewed the intervention positively and reported several benefits, such as feeling more energised, alert, focused and productive; however, the extent to which participants engaged with the intervention varied across groups. Scientific summary Background High levels of sedentary behaviour (e.g. sitting, reclining or lying, and expending ≤ 1.5 metabolic equivalents) have been linked to poor health outcomes, including type 2 diabetes, cardiovascular disease, some cancers and premature mortality. In addition to physiological health outcomes, high levels of sitting are detrimentally associated with cognitive function, mental health and a lower quality of life. Working-age adults spend around 60–70% of their workday sitting, with workdays being more sedentary than non-workdays; however, this can vary by occupation. Office workers spend 70–85% of their time at work sitting and accumulate a large proportion (40–50%) of this time in prolonged sitting bouts. Office workers also typically spend a large proportion of their leisure time sitting, compared with other occupations. In the workplace, lower levels of sitting have been linked to higher work vigour, higher job performance and lower presenteeism. Workplaces are, therefore, an ideal setting for implementing interventions to reduce daily sitting. Current evidence shows a need for fully powered randomised controlled trials (RCTs) with long-term follow-up to test the effectiveness of interventions to reduce sitting. Previous work from our group, evaluating multicomponent interventions to address high levels of sitting in office workers, found that significant reductions in sitting time across the day were mainly driven by changes to workplace sitting and to not daily sitting, indicating that a whole-day approach to encourage reductions in daily sitting was needed to maximise the potential health benefits. Objectives The main aim of the study was to evaluate the clinical effectiveness and cost-effectiveness of the SMART Work & Life (SWAL) intervention (provided with and without a height-adjustable workstation) in a sample of desk-based office workers. If both interventions were shown to be effective in comparison with the control group, then a secondary aim would be to determine if one intervention was more clinically effective and cost-effective than the other. Primary objective To investigate the impact of the SWAL intervention, delivered with and without a height-adjustable workstation, on device-assessed daily sitting time compared with usual practice at 12 months’ follow-up. Secondary objectives To investigate the impact of the SWAL intervention, delivered with and without a height-adjustable workstation, over the short term (assessed at 3 months) and longer term (assessed at 12 months) on: daily sitting time on any valid day (3 months) and on workdays and non-workdays sitting time during work hours daily time spent standing and in light and moderate or vigorous physical activity (MVPA) across any valid day, during work hours and on workdays and non-workdays daily time spent stepping and number of steps across any valid day, during work hours and on workdays and non-workdays markers of adiposity [i.e. body mass index (BMI), per cent body fat, waist circumference] blood pressure blood biomarkers [i.e. fasting glucose, cholesterol, triglycerides, glycated haemoglobin (HbA1c)] musculoskeletal health psychosocial health (i.e. fatigue, stress, anxiety and depression, well-being and quality of life) work-related health and performance (i.e. work engagement, job performance and satisfaction, occupational fatigue, presenteeism, sickness absence) sleep duration and quality. To undertake a full economic analysis of the SWAL intervention. To conduct a mixed-methods process evaluation throughout the intervention implementation period (using qualitative and quantitative measures) with participants and workplace champions. Methods Design A three-arm cluster RCT with a cost-effectiveness and process evaluation analysis. Follow-up measures were taken at 3 and 12 months. Setting Local councils in Leicester, Leicestershire, Greater Manchester and Liverpool, UK. Participants Participants were recruited from across participating councils (i.e. Leicester City Council, Leicestershire County Council, Salford City Council, Bolton Council, Trafford Council and Liverpool City Council). Participants were office-based employees (aged ≥ 18 years) who spent the majority (≥ 50%) of their day sitting, were at least 60% full-time equivalent and were able to walk without assistance. Employees who were pregnant, who already used a height-adjustable workstation or were unable to communicate in English were not eligible. Participants were grouped into clusters either by a shared office space (although could be made up of different teams/departments) or if they were members of the same team but split into different office spaces. To be eligible, each cluster was required to have at least one participant willing to undertake the role of workplace champion and at least four participants in the cluster. Informed consent was obtained from participants before the baseline measurement session and verbal consent was confirmed at each follow-up. Sample size To detect a 60-minute difference in average daily sitting time between the intervention groups and the control group [assuming a sitting time standard deviation (SD) of 90 minutes, 90% power, a two-tailed significance level of 5%, an average cluster size of 10 (range 4–38), an intraclass correlation coefficient of 0.05, the number of clusters being inflated by a factor of 1.23, allowing for one cluster drop out per arm and a 40% loss to follow-up/non-compliance with the activPAL (PAL Technologies Ltd, Glasgow, UK)], the required sample size was 690 participants from 72 clusters. Testing two intervention arms independently with the control arm was also taken account of as part of the sample size calculation. Interventions The SWAL intervention is a multicomponent intervention grounded in several behaviour change theories, which aims to reduce daily sitting in office workers. The SWAL intervention includes organisational-level behaviour change strategies (e.g. management buy-in), environmental-level behaviour change strategies (e.g. relocating waster bins, printers) and group-/individual-level behaviour change strategies (e.g. education, action-planning, goal-setting, addressing barriers, group coaching, challenges, self-monitoring) that are delivered by workplace champions. After all baseline measures were carried out, clusters were randomised to one of the following three conditions: (1) SWAL only, (2) the SWAL intervention with the addition of a height-adjustable workstation (i.e. SWAL plus desk) or (3) the control group. Randomisation was stratified by area (i.e. Leicester, Salford or Liverpool) and cluster size [i.e. small (< 10 people) or large (≥ 10 people)]. A team independent to the research team were responsible for training the workplace champions, but two members of the research team distributed resources to the workplace champions and were, therefore, unable to be blinded to allocation arm. Main outcome measures Primary outcome Outcome measures were collected at baseline and at 3 and 12 months by researchers who underwent relevant training. The primary outcome was difference in average daily sitting time (measured using the activPAL device) compared with usual practice at 12 months’ follow-up. Secondary outcomes Secondary outcomes from the activPAL device were analysed for the following four different time periods: (1) all waking hours (i.e. daily variables) on any valid day, (2) work hours only, (3) daily variables on workdays and (4) daily variables on non-workdays. Variables included sitting, standing and stepping time, time in prolonged sitting bouts, light physical activity and MVPA, number of steps and number of sit-to-stand transitions. The Axivity accelerometer (Axivity Ltd, Newcastle upon Tyne, UK) worn on the wrist was used to assess physical activity intensity, as well as sleep duration and efficiency. Data were collected on adiposity (i.e. BMI, fat percentage, waist circumference), and blood pressure and finger prick blood samples were collected to measure HbA1c, cholesterol (i.e. high-density lipoprotein, low-density lipoprotein and total), triglycerides and fasting blood glucose. At each measurement session, a questionnaire booklet queried self-reported sitting behaviours, musculoskeletal health, self-reported sleep, psychosocial variables, work-related health and performance, organisation social norms, cohesion and support, and dietary behaviours. The primary outcome analysis was performed using a linear multilevel model, using the complete-case analysis. Several sensitivity analyses were conducted, including intention to treat (ITT), per protocol, standardising waking and work hours, and the effect of a different number and type of valid activPAL days. Prespecified subgroup analyses were undertaken to investigate if the intervention had a different effect by area, cluster size, full-time/part-time workers, sex, age and BMI. Economic evaluation The economic analysis consisted of the following: a descriptive assessment of resource use, costs and outcomes a cost-effectiveness analysis with costs and quality-adjusted life-years (QALYs) estimated within the trial period and extrapolated over the individuals’ lifetimes, with a decision-analytic model from the public sector perspective in the base case a series of sensitivity, scenario and threshold analyses considering the impacts of key uncertainties on base-case findings a secondary cost–consequence and cost-effectiveness analysis based on observed differences between secondary outcomes within the trial period. Process evaluation A full process evaluation was carried out to assess recruitment, intervention implementation and participation, intervention sustainability, intervention contamination and unexpected events arising from the intervention and study. Qualitative and quantitative data were collected using a range of questionnaires (at 3 and 12 months), focus groups (at 12 months), interviews (at 15 months) and office observations (at 3 and 12 months). Results Recruitment A total of 78 clusters (756 participants) were randomised into the study [control arm, 26 clusters (n = 267); SWAL-only arm, 27 clusters (n = 249); SWAL plus desk arm, 25 clusters (n = 240)]. All clusters (100%) were followed up at 3 and 12 months, with 87.7% (n = 663) of participants seen at 3 months and 77.8% (n = 588) of participants seen at 12 months. At baseline, the mean age of participants was 44.7 (SD 10.5) years, 72.4% were female, 69.7% were white and mean BMI was 26.5 kg/m2 (SD 5.9 kg/m2). The percentage of time spent sitting was 64.2% ± 8.3% of daily wear time, with 51.9% ± 12.1% of daily sitting time accrued in prolonged bouts (≥ 30 minutes). Participants spent the majority of their time at work sitting (74.3% ± 11.7%) and over half of this time was accumulated in prolonged bouts (51.5% ± 19.0%). Primary outcome Valid accelerometer data were available for 547 (72.4%) participants for the primary outcome analysis. In the complete-case analysis, at 12 months, significant differences between groups were found in daily sitting time, with participants in the SWAL-only and SWAL plus desk arms sitting for 22.2 minutes per day [97.5% confidence interval (CI) –38.8 to –5.7 minutes/day; p = 0.003] and 63.7 minutes per day (97.5% CI –80.0 to –47.4 minutes/day; p < 0.001) less, respectively, than participants in the control group. Secondary outcomes SMART Work & Life plus desk was more effective than SWAL only by 41.7 minutes per day (95% CI –56.3 to –27.0 minutes/day; p < 0.001). For activPAL-assessed behaviours, there were numerous significant differences between the intervention groups and the control group. Work hours Differences were observed for prolonged sitting at 3 and 12 months for both intervention groups. In favour of the SWAL plus desk group, differences were observed for sitting time at 3 months, standing time at 3 and 12 months, and stepping time at 12 months. Workdays Differences were observed for sitting time and prolonged sitting at 3 and 12 months for both intervention groups, for standing time at 3 and 12 months for the SWAL plus desk group and for stepping time at 3 months for the SWAL-only group. Non-workdays No differences were observed. From the quantitative questionnaires, there were small beneficial differences in stress, well-being and vigour at 12 months for both intervention groups, and in pain in the lower extremity, social norms and support at 12 months for SWAL plus desk group. Sensitivity analyses Sensitivity analyses showed similar results to the primary analyses. Subgroup analyses For most subgroups, there were no significant interaction effects. For sitting time during work hours, there was a significant interaction for age, with the SWAL plus desk intervention having a greater effect for those aged ≥ 46 years. Health economics The average programme cost of the SWAL-only and SWAL plus desk interventions was £80.59 and £228.31 per ITT participant, respectively. Within trial, the SWAL-only intervention was found to have 0.84243 QALYs, £643 in public costs and an incremental cost-effectiveness ratio (ICER) of £12,091 per QALY. The SWAL plus desk intervention was dominated by SWAL only and control (0.84187 QALYs, £748 public costs). Over a lifetime horizon, the SWAL only and SWAL plus desk interventions had 17.80344 and 17.80766 QALYs, respectively, and ICERs of £4985 and £13,378 per QALY, respectively. Cost-effectiveness results were highly sensitive to age, longevity of treatment effect and costs. Process evaluation The process evaluation showed that the extent of intervention delivery and engagement varied considerably across clusters. Participants viewed the intervention very positively, although it was clear that usefulness of the different components varied across participants, indicating that a ‘one size fits all’ approach does not work and that different strategies will work for different people. Participants in both intervention groups identified many strategies that they adopted to reduce and break up their sitting time, which included standing and moving activities. These strategies were reported at work and at home, but participants did acknowledge that it was more of a challenge to reduce and break up sitting time at home. The favourable changes seen in the intervention groups for stress and well-being were supported, with participants reporting several benefits, such as feeling more energised and being more alert, focused and productive, and many participants in the SWAL plus desk group also reporting attenuation of previous musculoskeletal issues and fewer aches and pains. Conclusions Our SWAL intervention, provided with and without a height-adjustable workstation, was effective, with both groups sitting less than the control group in the short and longer term. The addition of the height-adjustable workstation was found to be three times more effective than the intervention provided on its own. Reductions in sitting time were replaced largely by increases in standing time, and changes in daily behaviour were driven by changes occurring during work hours on workdays. From the questionnaires, there were small beneficial changes for the intervention groups for levels of stress, well-being, vigour and pain the lower extremity, findings that were supported by the process evaluation. Our process evaluation data showed that the intervention was seen in a positive light and workplace champions and participants engaged with our intervention, but this did vary considerably across clusters and by intervention strategy. The economic evaluation found that the SWAL-only and SWAL plus desk interventions are potentially cost-effective strategies for promoting the