scholarly journals The feasibility and acceptability of a classroom-based physical activity program for children attending specialist schools: a mixed-methods pilot study

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Chloe Emonson ◽  
Nicole Papadopoulos ◽  
Nicole Rinehart ◽  
Ana Mantilla ◽  
Ian Fuelscher ◽  
...  

Abstract Background Children with disabilities often engage in less than the recommended amount of daily physical activity (PA). Classroom-based PA breaks are a favourable method of promoting PA for children. However, evaluations of these programs in specialist schools are scarce, with even less research into their feasibility and acceptability. This may hinder effective implementation and program scalability. This pilot study investigated the feasibility and acceptability of implementing a classroom-based PA break program in Australian specialist school classrooms, using the Australian Joy of Moving (AJoM) program. Methods Forty primary/junior classes and their teachers across five specialist schools implemented the AJoM program for eight weeks as the intervention group within a pilot cluster randomised controlled trial. A mixed-methods design investigated classroom teachers’ (N = 22; 6 males, 16 females) perspectives of the feasibility and acceptability of the program after implementation through semi-structured telephone interviews (n = 7 teachers), qualitative survey responses (n = 18 teachers) and quantitative survey items (n = 19 teachers). Qualitative data were analysed using predominantly deductive thematic analysis. Quantitative data were analysed using descriptive statistics. Results Classroom-based PA breaks may be feasible for getting children with disabilities more active at school. However, considerable variation exists in teachers’ perception of the AJoM experience. While several teachers indicate that the program content could be pertinent for their class, common divergences in perceptions of feasibility and acceptability appear to relate to the age and developmental level or needs of the students in the class. Conclusions This study provides preliminary evidence for the feasibility and acceptability of implementing classroom-based PA breaks in specialist schools. However, results demonstrate the importance of (1) allowing a high level of flexibility in the design and implementation of programs to meet the varying needs of class groups and (2) providing a large variety of resources to cater to the heterogeneity of the children. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000193178) on 11 February 2019.

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  

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).


Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
D. S. Epstein ◽  
J. C. Enticott ◽  
H. J. Larson ◽  
C. Barton

Abstract Undertaking recruitment for research in schools is an effective way to recruit young people for research participation but it is not without its challenges. Gaining access and coordinating many levels of different organisations and stakeholders whose cooperation and approval are crucial all add time and sometimes logistical challenges for the research team. In addition, recruiting around sensitive research topics can elicit additional barriers to successful research. The research team aimed to conduct a pragmatic cluster randomised controlled trial involving schools in a local government region in Victoria, Australia, to assess the effect of a vaccination-based educational card game called “Vaxcards” on vaccine consent returns. Schools were contacted via phone and email to determine which staff member would best be a contact point for a face-to-face meeting to discuss the methods and purpose of the study. Email follow-ups were scheduled to follow up non-responsive schools and consent forms. The minimum required sample size was 13. Of 31 eligible schools, 13 were recruited. The research team encountered several unanticipated challenges before achieving the recruitment target. The most common reasons for non-participation were being too busy with other commitments, concerns regarding the topic of vaccination being too sensitive, and concerns that key stakeholders in the school would not approve of the research topic of vaccination. One school required a review by a private research ethics board that rejected the study. Significant hesitancy and misinformation about vaccine science was observed that affected engagement with a small number of schools. This paper highlights the challenges of recruiting schools in the context of public anxieties about vaccines and has several important learning lessons for successful recruitment about sensitive topics. This includes navigating approval processes for research in schools, the importance of local champions, dealing with misinformation and the importance of strong relationships and organisational trust. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001753246. Prospectively registered on 25 October 2018 8:24:21 AM


Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035895
Author(s):  
Danielle Mazza ◽  
Natalie Amos ◽  
Cathy J Watson ◽  
Kevin McGeechan ◽  
Marion Haas ◽  
...  

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.


2021 ◽  
Author(s):  
Lisa Hynes ◽  
Andrew W Murphy ◽  
Nigel Hart ◽  
Collette Kirwan ◽  
Sarah Mulligan ◽  
...  

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.


2015 ◽  
Vol 3 (5) ◽  
pp. 1-210 ◽  
Author(s):  
Sally E Barber ◽  
Shaheen Akhtar ◽  
Cath Jackson ◽  
Daniel D Bingham ◽  
Catherine Hewitt ◽  
...  

BackgroundThe preschool years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood and establishing habitual physical activity early in life is therefore vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school-aged children. There are few preschool, playground-based interventions and these have given inconclusive results. A report published by the UK’s Chief Medical Officer (CMO) highlighted the need for new interventions to promote movement in the early years (0–5 years).ObjectivesThis study aimed to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged from 18 months to 4 years (Preschoolers in the Playground or PiP) and to assess the feasibility of conducting a full-scale cluster RCT.DesignThe study was a two-armed pilot cluster RCT with economic and qualitative evaluations. Participants were randomised on a 1 : 1 basis to the PiP intervention (n = 83) or usual practice (control;n = 81).SettingBradford, West Yorkshire, UK.ParticipantsChildren aged from 18 months to 4 years.InterventionThe PiP intervention is grounded in behavioural theory (social cognitive theory) and is in accordance with CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. The intervention was delivered in primary school playgrounds. Six 30-minute PiP sessions per week were available for 30 weeks; families were encouraged to come to three a week. The 10-week initiation phase was facilitated by a member of school staff and the maintenance phase was unsupervised.Main outcome measuresRecruitment and retention of schools and families to the trial were the main outcome measures. The acceptability of trial procedures and the intervention, the feasibility of collecting health outcome data and the fidelity of the implementation of the intervention were also evaluated. A preliminary assessment of cost-effectiveness and a sample size calculation for a full trial were conducted.ResultsIn total, 37% of schools and 48% of parents approached agreed to take part. Levels of retention were good at 10 and 52 weeks’ follow-up (82.3% and 83.5% respectively). Both the trial procedures and the intervention were acceptable. However, attendance was low during the autumn and winter/spring initiation phases but somewhat better in the summer initiation phase. Attendance was poor throughout all maintenance phases. The accelerometry protocol for measuring physical activity requires modification. The fidelity of intervention implementation was good (81% adherence). The intervention was borderline cost-effective. A sample size of 600 children from 38 schools is required for a full trial.ConclusionA full RCT of the PiP intervention is feasible. The PiP intervention requires some modification, for example running the intervention during the summer term only, but was found to be acceptable to schools and families.Trial registrationCurrent Controlled Trials ISRCTN54165860.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 5. See the NIHR Journals Library website for further project information.


2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  

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


Author(s):  
Samantha K. Stephens ◽  
Elisabeth A. H. Winkler ◽  
Elizabeth G. Eakin ◽  
Bronwyn K. Clark ◽  
Neville Owen ◽  
...  

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


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