Findings from a cluster randomised feasibility study of a school-based physical activity role model intervention (CHARMING) for 9-10-year-old girls.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Kelly Morgan, Jordan Van Godwin, Rebecca Cannings-John, Rhiannon Tudor Edwards, Rachel Granger, Britt Hallingberg, Graham Moore, Bethan Pell, Esther van Sluijs, Holly Whiteley, Jemma Hawkins
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引用次数: 0

Abstract

Background: Girls' physical activity levels decline to a greater extent than boys as they enter adolescence. Role model interventions offer a potential solution to combat this public health issue. This study reports findings of a feasibility study of the CHARMING (CHoosing Active Role Models to INspire Girls) programme, a 6-week after-school primary school-based, community linked, role-model intervention.

Methods: Between January 2021 and August 2022, a feasibility cluster randomised controlled trial (cRCT), with process and health economic evaluations was conducted in South Wales. Secondary schools were recruited, along with their adjoining primary schools to recruit Year 5 girls (aged 9-10 years). Role models were recruited from the surrounding school community (community role models) and from each secondary school (peer role models). A survey of self-reported outcome measures and accelerometers were administered at baseline and at 12 months. Following baseline, six primary schools were randomly allocated to intervention or control (usual practice) on a 2:1 basis. Post-intervention delivery, observations (n = 30), focus groups (n = 13) and interviews (n = 22) were conducted to explore study and intervention acceptability, feasibility and fidelity. Five pre-specified progression criteria included: implementation, attendance rates, and acceptability of the intervention, as well as completion of the primary outcome, including levels of completeness.

Results: One hundred and fifty-six girls from six primary schools (four intervention and two control) were eligible to take part. Of these, 96 (62%) and 97 (62%) Year 5 girls took part in the survey and accelerometer measures respectively, with 78 (81%) and 77 (79%) participating in the 12-month follow-up. Findings indicate that it is feasible to collect health-related quality of life information from 9- to 10-year-olds using a digital self-report survey completed in schools. Despite the impacts of the COVID-19 pandemic, three of the five criteria (implementation, acceptability and completion of primary outcome) for progressing to a full-scale evaluation were met. Process evaluation data provide understandings of why two criteria (attendance and completeness of the primary outcome) were not met. Overall, data suggest that acceptability and feasibility of the intervention were high, and that the intervention was broadly delivered as intended. Alterations to the study measures and the intervention were suggested to increase intervention acceptability and feasibility, including recruitment and retention and extending the length of delivery in line with original intentions (12 weeks).

Conclusions: Findings suggest the CHARMING intervention and cRCT design are likely to be acceptable and feasible, subject to further intervention and evaluation design optimisation.

Trial registration: ClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021.

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一项针对9-10岁女孩的基于学校的身体活动角色榜样干预(CHARMING)的聚类随机可行性研究的结果。
背景:进入青春期后,女孩的体力活动水平比男孩下降的程度更大。榜样干预措施为解决这一公共卫生问题提供了一个潜在的解决办法。本研究报告了“选择积极的榜样来激励女孩”项目可行性研究的结果,这是一个为期六周的小学课后、与社区相关的榜样干预项目。方法:在2021年1月至2022年8月期间,在南威尔士进行可行性聚类随机对照试验(cRCT),并进行过程和健康经济评估。中学及其毗邻的小学被招募为五年级女生(9-10岁)。从学校周围社区(社区榜样)和每所中学(同伴榜样)中招募榜样。在基线和12个月时进行自我报告结果测量和加速度计调查。根据基线,六所小学按2:1的比例随机分配到干预组或对照组(通常做法)。干预交付后,通过观察(n = 30)、焦点小组(n = 13)和访谈(n = 22)来探讨研究和干预的可接受性、可行性和保真度。五个预先指定的进展标准包括:实施、出勤率、干预的可接受性,以及主要结果的完成情况,包括完成程度。结果:来自6所小学的156名女生(4名干预,2名对照)符合条件。其中,分别有96名(62%)和97名(62%)五年级女生参加了调查和加速度计测量,其中78名(81%)和77名(79%)参加了为期12个月的随访。研究结果表明,使用在学校完成的数字自我报告调查来收集9至10岁儿童的健康相关生活质量信息是可行的。尽管受到COVID-19大流行的影响,但进入全面评估的五项标准(实施、可接受性和完成主要结果)中有三项达到了。过程评估数据提供了为什么两个标准(出席率和主要结果的完整性)没有达到的理解。总体而言,数据表明干预的可接受性和可行性很高,并且干预措施按预期广泛实施。建议改变研究措施和干预措施,以提高干预的可接受性和可行性,包括招募和保留,延长分娩时间符合初衷(12周)。结论:研究结果表明,在进一步的干预和评估设计优化中,CHARMING干预和cRCT设计可能是可接受和可行的。试验注册:ClinicalTrials.gov ISRCTN36223327。注册日期:2021年3月29日
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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