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A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study.

ABSTRACT: BACKGROUND:Patients with rheumatoid arthritis spend most of their daily hours in sedentary behavior (sitting), a predisposing factor to poor health-related outcomes and all-cause mortality. Interventions focused on reducing sedentary time could be of novel therapeutic relevance. However, studies addressing this topic remain scarce. We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological, metabolic and molecular effects in rheumatoid arthritis. METHODS:The Take a STAND for Health study is a 4-month, parallel-group, randomized controlled trial, in which postmenopausal patients with rheumatoid arthritis will set individually tailored, progressive goals to replace their sedentary time with standing and light-intensity activities. Patients will be recruited from the Clinical Hospital (School of Medicine, University of Sao Paulo) and will be assessed at baseline and after a 4-month follow up. Outcomes will include objectively measured sedentary behavior (primary outcome) and physical activity levels, clinical parameters, anthropometric parameters and body composition; aerobic fitness, muscle function, blood pressure, cardiovascular autonomic function, vascular function and structure, health-related quality of life, and food intake. Blood and muscle samples will be collected for assessing potential mechanisms, through targeted and non-targeted approaches. DISCUSSION:Findings will be of scientific and clinical relevance with the potential to inform new prescriptions focused on reducing sedentary behavior, a modifiable risk factor that thus far has been overlooked in patients with rheumatoid arthritis. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03186924. Registered on 14 June 2017.

SUBMITTER: Pinto AJ

PROVIDER: S-EPMC7014778 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study.

Pinto Ana Jessica AJ Peçanha Tiago T Meireles Kamila K Benatti Fabiana Braga FB Bonfiglioli Karina K de Sá Pinto Ana Lúcia AL Lima Fernanda Rodrigues FR Pereira Rosa Maria Rodrigues RMR Irigoyen Maria Claudia Costa MCC Turner James Edward JE Kirwan John P JP Owen Neville N Dunstan David W DW Roschel Hamilton H Gualano Bruno B

Trials 20200212 1

<h4>Background</h4>Patients with rheumatoid arthritis spend most of their daily hours in sedentary behavior (sitting), a predisposing factor to poor health-related outcomes and all-cause mortality. Interventions focused on reducing sedentary time could be of novel therapeutic relevance. However, studies addressing this topic remain scarce. We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological ...[more]

PMID: 32051025

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Project description:AimsType 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time.MethodsAdults aged 18-40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables.Results187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures.ConclusionsA structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change. Moreover, some participants reported a focus on physical activity rather than reductions in sitting per se. The habitual nature of sedentary behaviour means that behaviour change is challenging.Trial registrationControlled-Trials.com ISRCTN08434554.

Project description:ObjectivesTo test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary, overweight university employees.DesignBlinded, randomised controlled trial.SettingA large south-eastern university in the USA.Participants49 middle-aged, primarily female, sedentary and overweight adults working in sedentary jobs enrolled in the study. A total of 40 participants completed the study.InterventionsParticipants were randomised to either: (1) an intervention group (N=23; 47.6+9.9 years; 94.1% female; 33.2+4.5 kg/m(2)); (2) or wait-list control group (N=17; 42.6+8.9 years; 86.9% female; 31.7+4.9 kg/m(2)). The intervention group received a theory-based, internet-delivered programme, a portable pedal machine at work and a pedometer for 12 weeks. The wait-list control group maintained their behaviours for 12 weeks.Outcome measuresPrimary (sedentary and physical activity behaviour measured objectively through StepWatch) and secondary (heart rate, blood pressure, height, weight, waist circumference, per cent body fat, cardiorespiratory fitness, fasting lipids) outcomes were measured at baseline and postintervention (12 weeks). Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention.ResultsCompared to controls, the intervention group reduced daily sedentary time (mean change (95%CI): -58.7 min/day (-118.4 to 0.99; p<0.01)) after adjusting for baseline values and monitor wear time. Intervention participants logged on to the website 71.3% of all intervention days, used the pedal machine 37.7% of all working intervention days and pedalled an average of 31.1 min/day.ConclusionsThese findings suggest that the intervention was engaging and resulted in reductions in daily sedentary time among full-time sedentary employees. These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes.Trial registrationClinicalTrials.gov #NCT01371084.

Project description:BackgroundProlonged daily sedentary time is associated with increased risk of cardiometabolic diseases, impaired physical function, and mortality. Older adults are more sedentary than any other age group and those in assisted living residences accumulate more sedentary time as they often have little need to engage in light-intensity or standing activities such as cleaning or meal preparation. This "low movement" environment can hasten functional decline. Thus, the purpose of this study was to develop a multi-level intervention to reduce and interrupt sedentary time within assisted living residences and conduct a pilot study to determine if the intervention is feasible and if further testing is warranted.Methods"Stand When You Can" (SWYC) was developed using a Social Ecological framework based on a review of literature and consultation with residents and staff at assisted living residences. After development, a six-week pilot study was conducted in two different residences with 10 older adults (82.2 ± 8.7 years). Before and after the 6 weeks, ActivPAL™ inclinometers were used to measure daily movement behaviours and self-report questionnaires assessed time spent in different sedentary behaviours and quality of life. Physical function was assessed using the Short Physical Performance Battery. Paired sample t-tests examined pre-post differences for pooled data and individual sites. At the end of the pilot study, feedback on the intervention was gathered from both residents and staff to examine feasibility.ResultsThere was a trend towards a decrease in self-reported sitting time (142 min/day; p = 0.09), although device-measured sedentary time did not change significantly. Participants with lower physical function at baseline showed clinically meaningful improvements in physical function after the 6 weeks (p = 0.04, Cohen's d = 0.89). There was no change in quality of life. Residents and staff reported that the intervention strategies were acceptable and practical.ConclusionThis study suggests that a multi-level intervention for reducing prolonged sedentary time is feasible for implementation at assisted living residences. The intervention could potentially help delay functional decline among older adults when they transition to a supportive living environment. Longer and larger trials to test the efficacy of SWYC are necessary.Trial registrationName of Clinical Trial Registry: clinicaltrials.gov Trial Registration number: NCT04458896 . Date of registration: July 8, 2020. (Retrospectively registered).

Project description:BackgroundSedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. Excessive sedentary behaviour adversely affects health in children and adults. As sedentary behaviour tracks from childhood into adulthood, the reduction of sedentary time in young people is key for the prevention of chronic diseases that result from excessive sitting in later life. The sedentary school classroom represents an ideal setting for environmental change, through the provision of sit-stand desks. Whilst the use of sit-stand desks in classrooms demonstrates positive effects in some key outcomes, evidence is currently limited by small samples and/or short intervention durations, with few studies adopting randomised controlled trial (RCT) designs. This paper describes the protocol of a pilot cluster RCT of a sit-stand desk intervention in primary school classrooms.Methods/designA two-arm pilot cluster RCT will be conducted in eight primary schools (four intervention, four control) with at least 120 year 5 children (aged 9-10 years). Sit-stand desks will replace six standard desks in the intervention classrooms. Teachers will be encouraged to ensure all pupils are exposed to the sit-stand desks for at least 1 h/day on average using a rotation system. Schools assigned to the control arm will continue with their usual practice, no environmental changes will be made to their classrooms. Measurements will be taken at baseline, before randomisation, and at the end of the schools' academic year. In this study, the primary outcomes of interest will be school and participant recruitment and attrition, acceptability of the intervention, and acceptability and compliance to the proposed outcome measures (including activPAL-measured school-time and school-day sitting, accelerometer-measured physical activity, adiposity, blood pressure, cognitive function, academic progress, engagement, and behaviour) for inclusion in a definitive trial. A full process evaluation and an exploratory economic evaluation will also be conducted to further inform a definitive trial.DiscussionThe primary output of this study will be acceptability data to inform the development of a definitive cluster RCT designed to examine the efficacy of this intervention on health- and education-related outcomes in UK primary school children.Trial registrationISRCTN12915848 (retrospectively registered, date registered 9 November 2016).

Project description:BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n?=?62, aged 25-59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n?=?19), 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n?=?14), pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n?=?29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p?=?0.006) and during work hours (-1.7%, p?=?0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p?=?0.005) and during work hours (0.72, p?=?0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p?=?0.012) and MVPA on work days (0.6%, p?=?0.012). CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour. Participatory workplace interventions can reduce sedentary time, increase the frequency of breaks and improve light activity and MVPA of office workers by using a variety of interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTN12612000743864.

Project description:BACKGROUND:Older adults have high rates of obesity and are prone to chronic health conditions. These conditions are in part due to high rates of sedentary time (ST). As such, reducing ST could be an innovative strategy for improving health outcomes among obese older adults. To test this theory, we developed a novel, technology-enhanced intervention to reduce sitting time (I-STAND) and pilot tested it to assess the feasibility, acceptability, and preliminary effects of the intervention on ST and biometric outcomes. OBJECTIVE:The current paper aims to describe the rationale, design, and methods of the I-STAND sitting reduction pilot trial. METHODS:Older adults with obesity (n=60) were recruited from a large health care system and randomized to receive I-STAND or a healthy living intervention. I-STAND combined personal coaching with a technology-enhanced intervention (Jawbone UP band) to cue breaks from sitting. Participants completed self-report and biometric assessments at baseline and 3 months. Additional qualitative results were collected from a subset of I-STAND participants (n=22) to further inform the feasibility and acceptability of the interventions. The primary outcome was total hours of daily sitting time measured by the activPAL device. Secondary outcomes included sit-to-stand transitions, bouts of sitting longer than 30 minutes, physical function, blood pressure, fasting glucose, cholesterol, and depressive symptoms. RESULTS:Study enrollment has ended and data processing is underway. CONCLUSIONS:Data from randomized trials on sitting reduction are needed to inform novel approaches to health promotion among older adults with obesity. Our trial will help fill this gap. The methods used in our study can guide future research on using technology-based devices to assess or prompt sedentary behavior reduction, or those interested in behavioral interventions targeting obese older adults with novel approaches. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02692560; https://clinicaltrials.gov/ct2/show/NCT02692560 (Archived by WebCite at http://www.webcitation.org/6wppLTWAl).

Project description:BACKGROUND:High levels of sedentary behaviour (i.e., sitting) are a risk factor for poor health. With high levels of sitting widespread in desk-based office workers, office workplaces are an appropriate setting for interventions aimed at reducing sedentary behaviour. This paper describes the development processes and proposed intervention procedures of Stand More AT (SMArT) Work, a multi-component randomised control (RCT) trial which aims to reduce occupational sitting time in desk-based office workers within the National Health Service (NHS). METHODS/DESIGN:SMArT Work consists of 2 phases: 1) intervention development: The development of the SMArT Work intervention takes a community-based participatory research approach using the Behaviour Change Wheel. Focus groups will collect detailed information to gain a better understanding of the most appropriate strategies, to sit alongside the provision of height-adjustable workstations, at the environmental, organisational and individual level that support less occupational sitting. 2) intervention delivery and evaluation: The 12 month cluster RCT aims to reduce workplace sitting in the University Hospitals of Leicester NHS Trust. Desk-based office workers (n?=?238) will be randomised to control or intervention clusters, with the intervention group receiving height-adjustable workstations and supporting techniques based on the feedback received from the development phase. Data will be collected at four time points; baseline, 3, 6 and 12 months. The primary outcome is a reduction in sitting time, measured by the activPAL(TM) micro at 12 months. Secondary outcomes include objectively measured physical activity and a variety of work-related health and psycho-social measures. A process evaluation will also take place. DISCUSSION:This study will be the first long-term, evidence-based, multi-component cluster RCT aimed at reducing occupational sitting within the NHS. This study will help form a better understanding and knowledge base of facilitators and barriers to creating a healthier work environment and contribute to health and wellbeing policy. TRIAL REGISTRATION:ISRCTN10967042 . Registered 2 February 2015.

Dataset Information

A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study.

Publications

A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study.

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