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Background Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. Methods A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. Results Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. Conclusions Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population’s particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

Since the association between COVID-19 and ethnicity was first noted in April 2020,1 numerous large-scale national datasets have been analysed.2–6 The evidence is clear — ethnicity is a key risk factor for adverse COVID-19 outcome, alongside age, male sex, obesity, deprivation, and comorbidities.7 There are significant ethnic inequalities in the risk of admission to hospital and risk of death from COVID-19. Black and South Asian ethnic groups are at greatest risk, although most ethnic minorities have been shown to have increased risk when compared with white populations.7 Beyond admission to hospital and mortality risk, there is also concern over longer-term impacts, that is, post-acute COVID-19,8 which could significantly impact ethnic minority populations. As a result, Public Health England (PHE) released two evidence reviews and recommendations to address the disparities in COVID-19 outcomes in ethnic minority populations.9,10 PHE made only seven recommendations and these were lacking in detail, featuring issues that were already well articulated in minority health literature. The recommendations gave limited attention to the wider determinants of health that underpin ethnic disparities in COVID-19 outcomes, and gave no indication of timeframes for delivery or methods of implementation.10 In addition, the recommendations did not address how ethnic minority populations could best protect themselves during the pandemic. This was a significant oversight because personal and community responsibilities are imperative social determinants to protecting the health and wellbeing of ethnic minority communities when national (and regional) lockdown is eased. Subsequent to the PHE report there was an inevitable resurgence in COVID-19 cases over the summer months in areas with a high density of ethnic minorities such as Leicester,11 Blackburn, and Oldham. From mid-September, local COVID-19 restrictions were introduced across parts of the North West, North East, Midlands, and West Yorkshire. …

OBJECTIVE: The aim of the study was to investigate the impact of the COVID-19 pandemic and prevention measures on religious practices after death, by ethnic grouping, in an opportunistic/convenience sample of UK adults. METHODS: We distributed a questionnaire online and in hard copy between May 1 and June 18, 2020, via social media, post and face-to-face contact in Leicester, a multi-ethnic city in the UK. RESULTS: From 980 adults providing consent, 665 completed some or all survey items and provided ethnicity data. More than double the proportion of Black and South Asian individuals reported religious practices relating to death, burials or funerals being affected by COVID-19 than White groups. Of the 151 participants reporting practices being impacted, a greater proportion of ethnic minority groups reported restricted access/alteration to eight death-related practices (e.g., funeral attendance) compared with White groups (significantly different for all practices, P

BackgroundUK and global policies recommend whole-school approaches to improve childrens’ inadequate physical activity (PA) levels. Yet, recent meta-analyses establish current interventions as ineffective due to suboptimal implementation rates and poor sustainability. To create effective interventions, which recognise schools as complex adaptive sub-systems, multi-stakeholder input is necessary. Further, to ensure ‘systems’ change, a framework is required that identifies all components of a whole-school PA approach. The study’s aim was to co-develop a whole-school PA framework using the double diamond design approach (DDDA).MethodologyFifty stakeholders engaged in a six-phase DDDA workshop undertaking tasks within same stakeholder (n= 9; UK researchers, public health specialists, active schools coordinators, headteachers, teachers, active partner schools specialists, national organisations, Sport England local delivery pilot representatives and international researchers) and mixed (n= 6) stakeholder groupings. Six draft frameworks were created before stakeholders voted for one ‘initial’ framework. Next, stakeholders reviewed the ‘initial’ framework, proposing modifications. Following the workshop, stakeholders voted on eight modifications using an online questionnaire.ResultsFollowing voting, the Creating Active Schools Framework (CAS) was designed. At the centre, ethos and practice drive school policy and vision, creating the physical and social environments in which five key stakeholder groups operate to deliver PA through seven opportunities both within and beyond school. At the top of the model, initial and in-service teacher training foster teachers’ capability, opportunity and motivation (COM-B) to deliver whole-school PA. National policy and organisations drive top-down initiatives that support or hinder whole-school PA.SummaryTo the authors’ knowledge, this is the first time practitioners, policymakers and researchers have co-designed a whole-school PA framework from initial conception. The novelty of CAS resides in identifying the multitude of interconnecting components of a whole-school adaptive sub-system; exposing the complexity required to create systems change. The framework can be used to shape future policy, research and practice to embed sustainable PA interventions within schools. To enact such change, CAS presents a potential paradigm shift, providing a map and method to guide future co-production by multiple experts of PA initiatives ‘with’ schools, while abandoning outdated traditional approaches of implementing interventions ‘on’ schools.

ObjectivesThe aim of this study was to generate new evidence on how The Daily Mile (TDM), a popular school-based running programme in the UK, is implemented in a diverse and multiethnic city in the UK and also the barriers faced by non-implementer schools.DesignMixed method cross-sectional study (including survey data collection and qualitative interviews).SettingPrimary schools in a multiethnic city in the East Midlands, UK.ParticipantsForty-two schools in Leicester city completed an online survey, and five teaching staff from five schools took part in follow-up semistructured qualitative interviews.ResultsOverall, 40.5% of schools who completed the survey reported having never implemented TDM, and 96.0% of implementer schools reported delivering TDM on three or more days per week. Reported barriers included space limitations and safety issues, timetabling and curriculum pressures, and pupil and teacher attitudes. Facilitators of implementation were teacher engagement and school culture/ethos, communication of the initiative and substantial delivery adaptations.ConclusionsThe findings from this study, based on data from schools in a multiethnic city in the UK, suggest that implementation of TDM is variable, and is influenced by a range of factors related to the school context, as well as the characteristics of TDM itself.

The purpose of this study was to explore the feasibility of sit-to-stand desks in a middle school classroom. Participants used sit-to-stand desks during health class. Momentary time sampling was used for physical activity and behavioral observations. Results indicate students sat 37%, stood 59%, and walked 4% of the time. Misbehaviors occurred 4% of the observed period. The following themes emerged: focus, freedom, distractions, and design. Sit-to-stand desks appear to encourage standing during instruction while simultaneously limiting misbehaviors. Students indicated some distractions but were generally positive toward desk implementation and suggested they supported learning behaviors. The teacher echoed most of the student themes.

This study presents a worked example of a stepped process to reliably estimate the habitual physical activity and sedentary time of a sample of young children. A total of 299 children (2.9 ± 0.6 years) were recruited. Outcome variables were daily minutes of total physical activity, sedentary time, moderate to vigorous physical activity and proportional values of each variable. In total, 282 (94%) provided 3 h of accelerometer data on ≥1 day and were included in a 6-step process: Step-1: determine minimum wear-time; Step-2: process 7-day-data; Step-3: determine the inclusion of a weekend day; Step-4: examine day-to-day variability; Step-5: calculate single day intraclass correlation (ICC) (2,1); Step-6: calculate number of days required to reach reliability. Following the process the results were, Step-1: 6 h was estimated as minimum wear-time of a standard day. Step-2: 98 (32%) children had ≥6 h wear on 7 days. Step-3: no differences were found between weekdays and weekend days (P ≥ 0.05). Step-4: no differences were found between day-to-day variability (P ≥ 0.05). Step-5: single day ICC's (2,1) ranged from 0.48 (total physical activity and sedentary time) to 0.53 (proportion of moderate to vigorous physical activity). Step-6: to reach reliability (ICC = 0.7), 3 days were required for all outcomes. In conclusion following a 7 day wear protocol, ≥6 h on any 3 days was found to have acceptable reliability. The stepped-process offers researchers a method to derive sample-specific wear-time criterion.

Background There is growing interest in school-based interventions which deliver opportunities for additional physical activity time outside of physical education (PE). A practical and cost-effective approach may be school running programmes. Consequently, many school-based running initiatives are currently being implemented in a grass-roots style movement across the UK. However, research on the implementation of physical activity programmes in schools is notably underdeveloped. Therefore, this qualitative study aimed to better understand the barriers and facilitators to the implementation of a running programme, Marathon Kids (MK), within primary schools in England. Methods Two sets of semi-structured interviews were conducted, the first with each of the three core members of staff responsible for MK, and the second with each of the MK school staff Champions from 20 primary schools. Also, nine focus groups were conducted with 55 pupils (6–10 years) from five of the schools; all were analysed using thematic analysis. Results Three themes were identified surrounding the barriers and facilitators to implementation: features of the programme (e.g. ethos and resources), school climate (e.g. culture; whole school engagement; PE and physical activity policies and goals; and physical environment) and programme implementation decisions (e.g. aspirations and planning and sustainability). Conclusion Findings suggest that the barriers and facilitators to implementation are wide-ranging and include programme, organisational and system-level factors. Collectively pointing towards the need for a preparation period before implementation to understand schools’ readiness to implement and context-specific factors, both regarding organisational capacity and programme specific capacity. Electronic supplementary material The online version of this article (10.1186/s12889-018-6078-1) contains supplementary material, which is available to authorized users.

IntroductionChildren engage in a high volume of sitting in school, particularly in the classroom. A number of strategies, such as physically active lessons (termed movement integration (MI)), have been developed to integrate physical activity into this learning environment; however, no single approach is likely to meet the needs of all pupils and teachers. This protocol outlines an implementation study of a primary school-based MI intervention: CLASS PAL (Physically Active Learning) programme. This study aims to (A) determine the degree of implementation of CLASS PAL, (B) identify processes by which teachers and schools implement CLASS PAL and (C) investigate individual (pupil and teacher) level and school-level characteristics associated with implementation of CLASS PAL.Methods and analysisThe intervention will provide teachers with a professional development workshop and a bespoke teaching resources website. The study will use a single group before-and-after design, strengthened by multiple interim measurements. Six state-funded primary schools will be recruited within Leicestershire, UK.Evaluation data will be collected prior to implementation and at four discrete time points during implementation: At measurement 0 (October 2016), school, teacher and pupil characteristics will be collected. At measurements 0 and 3 (June–July 2017), accelerometry, cognitive functioning, self-reported sitting and classroom engagement data will be collected. At measurements 1(December 2016–March 2017) and 3 , teacher interviews (also at measurement 4; September–October 2017) and pupil focus groups will be conducted, and at measurements 1 and 2 (April–May 2017), classroom observations. Implementation will be captured through website analytics and ongoing teacher completed logs.Ethics and disseminationEthical approval was obtained through the Loughborough University Human Participants Ethics Sub-Committee (Reference number: R16-P115). Findings will be disseminated via practitioner and/or research journals and to relevant regional and national stakeholders through print and online media and dissemination event(s).

Objective To assess the effectiveness of 2 interventions in improving the physical activity and well-being of secondary school children. Design A clustered randomised controlled trial; classes, 1 per school, were assigned to 1 of 3 intervention arms or a control group based on a 2×2 factorial design. The interventions were peer-mentoring and participative learning. Year 7 children (aged 11–12) in the peer-mentoring intervention were paired with year 9 children for 6 weekly mentoring meetings. Year 7 children in the participative learning arm took part in 6 weekly geography lessons using personalised physical activity and Global Positioning System (GPS) data. Year 7 children in the combined intervention received both interventions, with the year 9 children only participating in the mentoring sessions. Participants 1494 year 7 students from 60 schools in the North of England took part in the trial. Of these, 43 students opted out of taking part in the evaluation measurements, 2 moved teaching group and 58 changed school. Valid accelerometry outcome data were collected for 892 students from 53 schools; and well-being outcome data were available for 927 students from 52 schools. Main outcome measures The primary outcomes were mean minutes of accelerometer-measured moderate-to-vigorous intensity physical activity per day, and well-being as evaluated by the KIDSCREEN-27 questionnaire. These data were collected 6 weeks after the intervention; a 12-month follow-up is planned. Results No significant effects (main or interaction) were observed for the outcomes. However, small positive differences were found for both outcomes for the participative learning intervention. Conclusions These findings suggest that the 2 school-based interventions did not modify levels of physical activity or well-being within the period monitored. Change in physical activity may require more comprehensive individual behavioural intervention, and/or more system-based efforts to address wider environmental influences such as family, peers, physical environment, transport and educational policy. Trial registration number ISRCTN82956355.

Background:Currently, no studies have investigated interinstrument reliability of the ActiGraph (AG) GT3X+ in free-living conditions.Methods:Nineteen adults (11 males, 8 females; aged 36.8 ± 11.9 years) wore a pair of AG’s (one on each hip), during all waking hours for 1 day. Raw outputs were generated for total counts, steps, wear time and mean counts per minute. Intensity outputs were derived for time (minutes) spent in Results:Interinstrument reliability was high (CV < 5%) for raw count and derived intensity outputs, except vigorous and very vigorous activity. ICC, CV, and APD values for vigorous and very vigorous were .97, 12.28, 17.36% and .98, 18.15, 25.67%, respectively. Amalgamating moderate, vigorous, and very vigorous into a single MVPA category reduced the CV and APD values to 2.85 and 4.02%, and increased the ICC value to .99. No significant differences were found between contralateral units for any outputs (P > .05).Conclusion:Reliability decreases beyond moderate intensities. MVPA displays superior interinstrument reliability than individual intensity categories. Research question permitting, reporting time in MVPA may maximize reliability.

This study examined dissonance in physical activity (PA) between two youth-specific hip-derived intensity cut-points for the Actiwatch (AW), and compared PA between hip and wrist placements using site-specific cut-points. Twenty-four children aged 11.2 ± 0.5 years wore the AW on the right hip and non-dominant wrist during a typical school day. Minutes of sedentary behaviour and vigorous activity were greater using Puyau et al. (2002) cut-points, but light, moderate, and moderate-to-vigorous (MVPA) were greater when derived using Puyau et al. (2004) cut-points (P < 0.01). Total hip activity counts were lower than wrist. Sedentary minutes were greater at the hip, but minutes of light, vigorous and MVPA were lower (P < 0.01). Moderate minutes were greater at the hip, but differed only when applying the Puyau et al. (2004) cut-points (P < 0.01). In conclusion, data comparisons between two hip derived AW cut-points and between hip and wrist data are inappropriate. Future researchers using the AW at the hip should present data reduced using both published cut-points. As hip and wrist data differ, the wrist placement is preferable as it will likely increase children's compliance to monitoring protocols due to reduced obtrusiveness compared to the hip.

Aware of the irony of writing about sedentary behaviour while sitting for prolonged periods most days, I type this viewpoint while pedalling on a micro-exercise bike that fits underneath my desk. In early February of this year the Canadian Society for Exercise Physiology (CSEP) released guidelines on sedentary behaviour among children and young people aged 5 to 17. These are the first evidence based guidelines published on this topic, and they mark an important shift in the appreciation of sedentary behaviour as an independent health risk. Over the past decade researchers have begun to redefine our understanding of what constitutes sedentary behaviour, shifting the focus from simply the absence of sufficient health enhancing physical activity. Some research groups now posit that sedentarism is the engagement in a separate class of behaviours characterised by minimal movement and low energy expenditure—for example, sitting or watching television. Research is now showing that prolonged sedentary behaviour is independently and positively associated with …