scholarly journals Temporal features of sitting, standing and stepping changes in a cluster-randomised controlled trial of a workplace sitting-reduction intervention

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Samantha K. Stephens ◽  
Elisabeth A. H. Winkler ◽  
Elizabeth G. Eakin ◽  
Bronwyn K. Clark ◽  
Neville Owen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Work Hours ◽  
Trial Registration ◽  
Sitting Time ◽  
Work Time ◽  
Prolonged Sitting ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background There is now a body of evidence on the effectiveness of interventions to reduce workplace sitting time. However, there has been limited reporting of how such interventions may impact behaviour both during and outside of work. Sitting, standing and stepping changes following a workplace intervention were examined across five timeframes (work time on work days; non-work time on work days; work days; non-work days; overall (i.e. work and non-work time on all days)), and the relationships between changes during and outside of work was assessed. Methods The cluster-randomised controlled trial, ‘Stand Up Victoria’, delivered a multi-component workplace-delivered intervention that successfully reduced workplace and overall sitting time (relative to controls). Separately, over the five timeframes, changes in device (activPAL3)-assessed outcomes — sitting; prolonged sitting (≥30 min bouts); standing; and, stepping — were compared between intervention (n = 114) and controls (n = 84), along with the time-course of sitting changes during work hours, using mixed models. The potential relationships of changes during work with changes outside of work were examined using compositional data analysis. Results On workdays, intervention participants significantly (p < 0.05) improved their activity profile relative to controls, with reduced sitting (− 117 min/8-h workday, 95% CI: − 141, − 93) and prolonged sitting (− 77 min/8 h workday, 95% CI: − 101, − 52); increased standing (114 min/8 h workday, 95% CI: 92, 136) and maintenance of stepping (3 min/8 h workday, 95% CI: − 7, 11, p = 0.576). Effects were nearly identical for time at work; similar but slightly weaker for overall; and, small and non-significant outside of work on workdays and non-work days. Improvements occurred at all times, but not equally, during work hours (p < 0.001). Correlations between changes during and outside of work on workdays were very weak in both the intervention group (r = − 0.07) and controls (r = − 0.09). Conclusions Sitting time was reduced almost exclusively during work hours (via replacement with standing), with reductions evident during all working hours, to varying degrees. There was no evidence of compensation, with minimal change in activity outside of work, in response to changes in activity at work. Future interventions may benefit from exploring how best to elicit change throughout the whole day, and across work and non-work domains. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials register (ACTRN12611000742976) on 15 July 2011

Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Resource Assessment ◽  
Trial Registration ◽  
Residential Aged Care ◽  
Cluster Randomised ◽  
Intervention Adherence ◽  
Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

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

2020 ◽  
Vol 8 (8) ◽  
pp. 1-126
Author(s):  
Stacy A Clemes ◽  
Daniel D Bingham ◽  
Natalie Pearson ◽  
Yu-Ling Chen ◽  
Charlotte Edwardson ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Health Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Sitting Time ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

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.

scholarly journals A cluster-randomised controlled trial comparing school and community-based deworming for soil transmitted helminth control in school-age children: the CoDe-STH trial protocol

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Naomi E. Clarke ◽  
Dinh Ng-Nguyen ◽  
Rebecca J. Traub ◽  
Archie C. A. Clements ◽  
Kate Halton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
School Age Children ◽  
School Age ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Current guidelines and targets for soil-transmitted helminth (STH) control focus on school-based deworming for school-age children, given the high risk of associated morbidity in this age group. However, expanding deworming to all age groups may achieve improved STH control among both the community in general and school-age children, by reducing their risk of reinfection. This trial aims to compare school-based targeted deworming with community-wide mass deworming in terms of impact on STH infections among school-age children. Methods The CoDe-STH (Community Deworming against STH) trial is a cluster-randomised controlled trial (RCT) in 64 primary schools in Dak Lak province, Vietnam. The control arm will receive one round of school-based targeted deworming with albendazole, while in the intervention arm, community-wide mass deworming with albendazole will be implemented alongside school-based deworming. Prevalence of STH infections will be measured in school-age children at baseline and 12 months following deworming. The primary outcome is hookworm prevalence in school-age children at 12 months, by quantitative PCR. Analysis will be intention-to-treat, with outcomes compared between study arms using generalised linear and non-linear mixed models. Additionally, cost-effectiveness of mass and targeted deworming will be calculated and compared, and focus group discussions and interviews will be used to assess acceptability and feasibility of deworming approaches. Individual based stochastic models will be used to predict the impact of mass and targeted deworming strategies beyond the RCT timeframe to assess the likelihood of parasite population ‘bounce-back’ if deworming is ceased due to low STH prevalence. Discussion The first large-scale trial comparing mass and targeted deworming for STH control in South East Asia will provide key information for policy makers regarding the optimal design of STH control programs. Trial registration ACTRN12619000309189.

scholarly journals Recruiting general practitioners and patients with dementia into a cluster randomised controlled trial: strategies, barriers and facilitators

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sonia Lech ◽  
Julie L. O’Sullivan ◽  
Leonard Wellmann ◽  
Juliana Supplieth ◽  
Susanne Döpfmer ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
General Practitioners ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Trial Registration ◽  
Research Network ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Recruitment of general practitioners (GPs) and their patients is reported as one of the most challenging steps when undertaking primary care research. The present paper describes the recruitment process of a cluster randomised controlled trial (cRCT) aiming to improve dementia care in the primary care setting. Methods Recruitment data was analysed descriptively using frequency tables to investigate comparisons of recruitment rates and results of different recruitment strategies as well as reasons for participation and non-participation of GPs, patients with dementia (PwD) and their caregivers. Results Over a period of 23 months, N = 28 GPs were successfully included in the cRCT. This represents an overall recruitment rate of 4.6%. The most efficient strategy in terms of high response and low labour-intensity involved the dissemination of calls for participation in a GP research network. Most frequently reported reasons for GP’s participation were Improvement of patient’s well-being (n = 22, 79%) followed by Interest in dementia research (n = 18, 64%). The most common reasons for non-participation were Lack of time (n = 71, 34%) followed by Not interested in participation (n = 63, 30%). On a patient level, N = 102 PwD were successfully recruited. On average, each GP referred about n = 7 PwD (range: 1–17; mdn = 6; IQR = 3.5) and successfully recruited about n = 4 PwD (range: 1–11; mdn = 3; IQR = 3.5). Conclusion First, our findings propose GP research networks as a promising strategy to promote recruitment and participation of GPs and their patients in research. Second, present findings highlight the importance of including GPs and their interests in specific research topics in early stages of research in order to ensure a successful recruitment. Finally, results do not support cold calls as a successful strategy in the recruitment of GPs. Trial registration The trial was prospectively registered with the ISRCTN registry (Trial registration number: ISRCTN15854413). Registered 01 April 2019.

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