scholarly journals A school-based intervention (‘Girls Active’) to increase physical activity levels among 11- to 14-year-old girls: cluster RCT

2019 ◽  
Vol 7 (5) ◽  
pp. 1-162 ◽  
Author(s):  
Deirdre M Harrington ◽  
Melanie J Davies ◽  
Danielle Bodicoat ◽  
Joanna M Charles ◽  
Yogini V Chudasama ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Research ◽  
Sedentary Time ◽  
Data Interpretation ◽  
Analysis Data ◽  
Public Health Research ◽  
Steering Committee ◽  
Trial Steering Committee ◽  
Clinical Trials Unit ◽  
Secondary Outcomes

BackgroundPhysical activity (PA) levels among adolescent girls in the UK are low. ‘Girls Active’, developed by the Youth Sport Trust (YST), has been designed to increase girls’ PA levels.ObjectiveTo understand the effectiveness and cost-effectiveness of the Girls Active programme.DesignA two-arm cluster randomised controlled trial.SettingState secondary schools in the Midlands, UK.ParticipantsGirls aged between 11 and 14 years.InterventionGirls Active involves teachers reviewing PA, sport and physical education provision, culture and practices in their school; attending training; creating action plans; and effectively working with girls as peer leaders to influence decision-making and to promote PA to their peers. Support from a hub school and the YST is offered.Main outcome measuresThe change in objectively measured moderate to vigorous intensity PA (MVPA) levels at 14 months. Secondary outcomes included changes in overall PA level (mean acceleration), light PA levels, sedentary time, body composition and psychosocial outcomes. Cost-effectiveness and process evaluation (qualitative and quantitative) data were collected.ResultsTwenty schools and 1752 pupils were recruited; 1211 participants provided complete primary outcome data at 14 months. No difference was found in mean MVPA level between groups at 14 months [1.7 minutes/day, 95% confidence interval (CI) –0.8 to 4.3 minutes/day], but there was a small difference in mean MVPA level at 7 months (2.4 minutes/day, 95% CI 0.1 to 4.7 minutes/day). Significant differences between groups were found at 7 months, but not at 14 months, in some of the objective secondary outcomes: overall PA level represented by average acceleration (1.39 mg, 95% CI 0.1 to 2.2 mg), after-school sedentary time (–4.7 minutes/day, 95% CI –8.9 to –0.6 minutes/day), overall light PA level (5.7 minutes/day, 95% CI 1.0 to 10.5 minutes/day) and light PA level on school days (4.5 minutes/day, 95% CI 0.25 to 8.75 minutes/day). Minor, yet statistically significant, differences in psychosocial measures at 7 months were found in favour of control schools. Significant differences in self-esteem and identified motivation in favour of intervention schools were found at 7 and 14 months, respectively. Subgroup analyses showed a significant effect of the intervention for those schools with higher numbers of pupils at 14 months. Girls Active was well received by teachers, and they reported that implemented strategies and activities were having a positive impact in schools. Barriers to implementation progress included lack of time, competing priorities and the programme flexibility. Implementation costs ranged from £2054 (£23/pupil) to £8545 (£95/pupil) per school. No differences were found between groups for health-related quality-of-life scores or frequencies, or for costs associated with general practitioner, school nurse and school counsellor use.ConclusionsGirls Active may not have had an effect on the random 90 girls per school included in the evaluation. Although we included a diverse sample of schools, the results may not be generalisable to all schools. Girls Active was viewed positively but teachers did not implement as many aspects of the programme as they wanted. The intervention was unlikely to have a wide impact and did not have an impact on MVPA level at 14 months. Capitalising on the opportunities of a flexible programme like this, while also learning from the stated barriers to and challenges of long-term implementation that teachers face, is a priority for research and practice.Trial registrationCurrent Controlled Trials ISRCTN10688342.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 7, No. 5. See the NIHR Journals Library website for further project information. The YST funded the intervention. This study was undertaken in collaboration with the Leicester Clinical Trials Unit, a UK Clinical Research Collaboration-registered clinical trials unit in receipt of NIHR Clinical Trials Unit support funding. Neither the YST nor the NIHR Clinical Trials Unit had any involvement in the Trial Steering Committee, data analysis, data interpretation, data collection or writing of the report. The University of Leicester authors are supported by the NIHR Leicester–Loughborough Biomedical Research Unit (2012–17), the NIHR Leicester Biomedical Research Centre (2017–22) and the Collaboration for Leadership in Applied Health Research and Care East Midlands. These funders had no involvement in the Trial Steering Committee, the data analysis, data interpretation, data collection or writing of the report.

scholarly journals What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Anne Daykin ◽  
Lucy E. Selman ◽  
Helen Cramer ◽  
Sharon McCann ◽  
Gillian W. Shorter ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Steering Committee ◽  
Trial Steering Committee ◽  
Ethnographic Study

scholarly journals Public Health Research Ethics and Clinical Research Ethics. How we differentiate?

2019 ◽  
Vol 9 (2) ◽  
pp. 22-25
Author(s):  
Zoheb Rafique
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Research ◽  
Research Ethics ◽  
Health Research ◽  
Public Health Research

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection of individual participants and some of the research norms and accepted principles may be challenging when applying in some of the research contexts.  

scholarly journals A peer-led physical activity intervention in schools for adolescent girls: a feasibility RCT

2019 ◽  
Vol 7 (16) ◽  
pp. 1-178
Author(s):  
Simon J Sebire ◽  
Kathryn Banfield ◽  
Rona Campbell ◽  
Mark J Edwards ◽  
Ruth Kipping ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Adolescent Girls ◽  
Health Research ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Public Health Research ◽  
Clinical Trials Unit ◽  
Data Provision ◽  
Randomised Controlled

Background Girls are less active than boys and few adolescent girls meet physical activity (PA) guidelines. Peers are an important influence on the views and behaviours of adolescent girls, yet many PA interventions involving peers use formal approaches that may not harness the power of peer groups. More informal peer-led PA interventions, which work within proximal peer groups, may hold promise for increasing girls’ PA. Objectives To examine the feasibility, evidence of promise and cost of the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led PA intervention. Design Phase 1 comprised formative work and a pilot study conducted in one secondary school. Phase 2 was a feasibility study comprising a pilot randomised controlled trial in six secondary schools, including process and economic evaluations. Setting Six secondary schools in South Gloucestershire and Wiltshire, recruited from schools above the median local Pupil Premium (i.e. more deprived). Participants Year 8 girls (aged 12–13 years). Intervention Year 8 girls nominated other girls in their year who are likely to be influential (e.g. who they look up to, are good listeners); the 18% most nominated were invited to be peer supporters (PSs). PSs attended 2 consecutive days of training (plus a top-up day 5 weeks later) outside the school site, led by pairs of PS trainers, to increase their knowledge about PA and their capabilities and confidence to promote PA in their friendship group. Main outcome measures Measures focused on establishing evidence for feasibility and promise: recruitment and retention of Year 8 girls and PSs, data provision rates [accelerometer and questionnaire collected pre randomisation/beginning of Year 8 (T0), end of Year 8 (T1) and beginning of Year 9 (T2)], intervention acceptability, PS training attendance, intervention cost, and the between-arm difference in weekday minutes of moderate to vigorous PA (MVPA). A process evaluation was conducted. Results Six schools were recruited: four PLAN-A (n = 269) and two control (n = 158). In total, 94.7% of Year 8 girls participated. A total of 55 (17–24% of Year 8 girls) PSs were trained (attendance rate 91–100%). Five girls were trained as PS trainers. Questionnaire data provision exceeded 92% at all time points. Accelerometer return rates were > 85% and wear-time criteria were met by 83%, 71% and 62% of participants at T0, T1 and T2, respectively. Mean weekday MVPA did not differ between intervention arms at T1 (1.1 minutes, 95% CI –4.3 to 6.5 minutes) but did at T2 (6.1 minutes, 95% CI 1.4 to 10.8 minutes), favouring PLAN-A. The mean cost of intervention delivery was £2685 per school or £37 per Year 8 girl. Process evaluation identified good fidelity, engagement and enjoyment of the PS training and peer-support strategies. PSs needed more guidance on how to start conversations. Limitations Accelerometer data provision was lowest at T2, suggesting a need for strategies to increase compliance. Conclusions Informal peer-led intervention approaches, such as PLAN-A, hold promise as a means of promoting PA to adolescent girls. Future work A definitive randomised controlled trial of PLAN-A is warranted. Trial registration Current Controlled Trials ISRCTN12543546. 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. 7, No. 16. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration (UKCRC) Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UKCRC, is gratefully acknowledged. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK CRC-registered clinical trials unit in receipt of NIHR clinical trials unit support funding. The intervention costs were jointly funded by South Gloucestershire Council and Wiltshire Council.

scholarly journals Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stefan Rennick-Egglestone
Keyword(s):  
Social Media ◽  
Clinical Trials ◽  
Health Research ◽  
Online Intervention ◽  
Ethics Committee ◽  
Promotional Material ◽  
Media Campaigns ◽  
Social Media Platforms ◽  
Ethical Oversight ◽  
Research Studies

AbstractSome health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effective social media campaigns might involve the production and dissemination of hundreds of contemporaneous messages. For the Narrative Experiences Online (NEON) study, we have developed nine principles to control the production and dissemination of promotional material. These have been approved by an ethics committee and enable the audit of our recruitment work. We propose that the drafting for approval of recruitment principles by health research studies may, in many cases, strike an appropriate balance between enabling ethical oversight of online recruitment work and the potential burden of message review.

scholarly journals Utilizing asynchronous email interviews for health research: overview of benefits and drawbacks

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Michelle Amri ◽  
Christina Angelakis ◽  
Dilani Logan
Keyword(s):  
Public Health ◽  
Data Collection ◽  
Data Quality ◽  
Health Research ◽  
Geographic Location ◽  
Public Health Research ◽  
Data Accuracy ◽  
Global Public Health ◽  
Snowball Sampling ◽  
Face To Face

Abstract Objective Through collating observations from various studies and complementing these findings with one author’s study, a detailed overview of the benefits and drawbacks of asynchronous email interviewing is provided. Through this overview, it is evident there is great potential for asynchronous email interviews in the broad field of health, particularly for studies drawing on expertise from participants in academia or professional settings, those across varied geographical settings (i.e. potential for global public health research), and/or in circumstances when face-to-face interactions are not possible (e.g. COVID-19). Results Benefits of asynchronous email interviewing and additional considerations for researchers are discussed around: (i) access transcending geographic location and during restricted face-to-face communications; (ii) feasibility and cost; (iii) sampling and inclusion of diverse participants; (iv) facilitating snowball sampling and increased transparency; (v) data collection with working professionals; (vi) anonymity; (vii) verification of participants; (viii) data quality and enhanced data accuracy; and (ix) overcoming language barriers. Similarly, potential drawbacks of asynchronous email interviews are also discussed with suggested remedies, which centre around: (i) time; (ii) participant verification and confidentiality; (iii) technology and sampling concerns; (iv) data quality and availability; and (v) need for enhanced clarity and precision.

scholarly journals Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sharon B. Love ◽  
Emma Armstrong ◽  
Carrie Bayliss ◽  
Melanie Boulter ◽  
Lisa Fox ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Remote Monitoring ◽  
Research Collaboration ◽  
Monitoring Task ◽  
Critical Data ◽  
Site Monitoring ◽  
Clinical Trials Unit ◽  
Third Person ◽  
Trial Monitoring ◽  
The Uk

AbstractThe COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring.Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.

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