Morgan Kelly, Van Godwin Jordan, Cannings-John Rebecca, Edwards Rhiannon Tudor, Granger Rachel, Hallingberg Britt, Moore Graham, Pell Bethan, van Sluijs Esther, Whiteley Holly, Hawkins Jemma
Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement (Decipher), Cardiff University, Spark, Maindy Road, Cardiff, CF24 4HQ, UK.
Centre for Trials Research, Cardiff University, Heath Park, Cardiff, CF14 4YS, UK.
Pilot Feasibility Stud. 2025 Apr 4;11(1):38. doi: 10.1186/s40814-025-01615-7.
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.
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.
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).
Findings suggest the CHARMING intervention and cRCT design are likely to be acceptable and feasible, subject to further intervention and evaluation design optimisation.
ClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021.
女孩进入青春期后，其身体活动水平下降的程度比男孩更大。榜样干预为解决这一公共卫生问题提供了一种潜在的解决方案。本研究报告了“魅力计划”（选择积极榜样激励女孩）的可行性研究结果，这是一项为期6周的基于小学课后、与社区相关联的榜样干预计划。
2021年1月至2022年8月，在南威尔士进行了一项可行性整群随机对照试验（cRCT），并进行了过程和健康经济评估。招募了中学及其相邻的小学，以招募五年级女生（9至10岁）。榜样从周边学校社区（社区榜样）和每所中学（同伴榜样）中招募。在基线和12个月时进行了自我报告结局指标调查和使用加速度计测量。基线后，六所小学以2:1的比例随机分配到干预组或对照组（常规做法）。干预后，进行了观察（n = 30）、焦点小组（n = 13）和访谈（n = 22），以探讨研究和干预的可接受性、可行性和保真度。五个预先设定的进展标准包括：干预的实施、出勤率、可接受性，以及主要结局的完成情况，包括完整程度。
来自六所小学（四所干预组和两所对照组）的156名女孩符合参与条件。其中，分别有96名（62%）和97名（62%）五年级女生参与了调查和加速度计测量，78名（81%）和77名（79%）参与了12个月的随访。研究结果表明，通过在学校完成的数字自我报告调查，从9至10岁儿童中收集与健康相关的生活质量信息是可行的。尽管受到新冠疫情的影响，但仍满足了五个标准中的三个（实施、可接受性和主要结局的完成情况），从而可以进行全面评估。过程评估数据有助于理解为何未满足两个标准（出勤率和主要结局的完整性）。总体而言，数据表明干预的可接受性和可行性较高，并且干预基本按预期实施。建议对研究措施和干预进行调整，以提高干预的可接受性和可行性，包括招募和留存方面，并按照原定计划（12周）延长实施时间。
研究结果表明，“魅力计划”干预和cRCT设计在经过进一步的干预和评估设计优化后，可能是可接受和可行的。
ClinicalTrials.gov ISRCTN36223327。2021年3月29日注册。
