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青少年女孩身体活动增强同伴主导的校本干预可行性整群随机对照试验(PLAN-A)方案的更新

Update to a protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

作者信息

Sebire Simon J, Edwards Mark J, Campbell Rona, Jago Russell, Kipping Ruth, Banfield Kathryn, Kadir Bryar, Garfield Kirsty, Lyons Ronan A, Blair Peter S, Hollingworth William

机构信息

Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK.

School of Social & Community Medicine, University of Bristol, Bristol, UK.

出版信息

Pilot Feasibility Stud. 2016 Dec 1;2:68. doi: 10.1186/s40814-016-0110-y. eCollection 2016.

Abstract

BACKGROUND

Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence, and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. In addition, this paper describes an update that has been made to the protocol for the PLAN-A feasibility cluster randomised controlled trial.

METHODS/DESIGN: A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention  = 4; control  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer supporters. Approximately 15% of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a definitive trial. A detailed process evaluation using qualitative and quantitative methods will be conducted with a variety of stakeholders (i.e. pupils, parents, teachers and peer-supporter trainers) to identify areas of success and necessary improvements prior to proceeding to a definitive trial.

DISCUSSION

The study will provide the information necessary to design a fully powered trial should PLAN-A demonstrate evidence of promise. This paper describes an update to the protocol for the PLAN-A feasibility cluster randomised controlled trial related to the data-linkage component.

TRIAL REGISTRATION

ISRCTN12543546.

摘要

背景

青春期女孩的身体活动水平较低,且这一群体在积极参与活动方面面临特定障碍。同伴对健康行为的影响在青春期很重要,由同伴主导的干预措施可能有望改变行为。本文描述了一项针对青春期女孩的同伴主导身体活动干预(PLAN - A)可行性整群随机对照试验的方案,这是一项旨在提高青春期女孩身体活动水平的同伴主导干预措施。此外,本文还描述了对PLAN - A可行性整群随机对照试验方案所做的更新。

方法/设计:将在六所中学(干预组 = 4所;对照组 = 2所)对八年级(12 - 13岁)女孩开展双臂整群随机可行性试验。干预将在年级层面进行,由八年级女孩在本年级内提名有影响力的同伴成为同伴支持者。约15%的队列将接受为期3天的身体活动和人际沟通技能培训。同伴支持者随后将在10周内非正式地向其朋友传播有关身体活动的信息。将在基线(时间0(T0))、干预结束后立即(时间1(T1))以及基线测量后12个月(时间2(T2))收集数据。在这项可行性试验中,主要关注点在于学校和参与者(八年级女孩和同伴支持者)的招募、干预的实施与接受情况、数据提供率以及确定未来经济分析的成本类别。将使用7天加速度计评估身体活动情况,在一项全面开展的试验中,可能的主要结局指标是每天中等至剧烈身体活动的分钟数。参与者还将在每个时间点完成心理社会调查问卷:评估动机、自尊和同伴身体活动规范。数据分析将主要是描述性的,重点关注招募、参与率和数据提供率。研究结果将为确定最终试验所需的样本量提供依据。在进行最终试验之前,将使用定性和定量方法对各种利益相关者(即学生、家长、教师和同伴支持者培训师)进行详细的过程评估,以确定成功领域和必要的改进之处。

讨论

如果PLAN - A显示出有前景的证据,该研究将提供设计全面开展试验所需的信息。本文描述了与数据链接部分相关的PLAN - A可行性整群随机对照试验方案的更新内容。

试验注册

ISRCTN12543546。

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