积极开始积极未来的研究方案:一项随机对照试验,针对生活在澳大利亚昆士兰州东南部的脑瘫幼儿的身体活动参与和久坐行为进行早期行为改变干预。

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Gaela Kilgour, Sarah Elizabeth Reedman, Sjaan R Gomersall, Leanne Sakzewski, Stewart Trost, Roslyn N Boyd
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引用次数: 0

摘要

身体活动(PA)的好处对所有年龄和能力的人都是引人注目的。对于脑瘫儿童,两种不同的健康行为,即身体活动和减少久坐时间,对于降低长期发病率的早期干预至关重要。一种方法可能是通过赋予父母权力来增加私人助理的参与,因为父母是改变家庭生活方式的关键。本研究将在一项混合方法随机候补对照试验中比较以参与为中心的干预措施Active Start Active Future和常规护理。方法和分析:共有40名CP儿童(3-7岁),被分类为大运动功能分类系统(GMFCS) II-V级,将被分层(GMFCS II vs III, IV vs V)并随机分配接受(1)主动开始主动未来,在任何环境下每周1小时的8周干预或(2)常规护理后延迟干预。Active Start Active Future旨在通过提供促进PA行为改变的参与性机会,增加PA并减少CP幼儿的久坐行为。结果将在基线(T1)、干预后立即在8周(T2)和基线后26周(T3)测量。主要的结果是加拿大职业绩效测量对儿童和家长参与目标和儿童身体表现目标的影响。次要结果包括每日中度至重度PA和久坐时间、大运动功能、生活质量、儿童和父母参与PA和久坐时间的障碍。干预的可接受性和PA参与的经验将使用定性描述的方法进行探讨。伦理和传播:昆士兰儿童健康医院和卫生服务人类研究伦理委员会(HREC/23/QCHQ/100850)和昆士兰大学人类研究伦理委员会(2024/HE000054)已经批准了这项研究。研究结果将在我们的咨询小组的指导下,以会议摘要和演讲、科学期刊上的同行评议文章、机构通讯和媒体发布的形式分发给家庭和社区机构。试验注册号:ACTRN12624000042549,通用试验号:U1111-1300-7421;澳大利亚新西兰临床试验登记处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study protocol for Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity participation and sedentary behaviour in young children with cerebral palsy living in South East Queensland, Australia.

Introduction: The benefits of physical activity (PA) are compelling for all ages and abilities. For children with cerebral palsy (CP), two distinct health behaviours, being physically active and reducing sedentary time, are critical to target as an early intervention to reduce long-term morbidity. One approach may be to increase PA participation by empowering parents who are key to making family lifestyle changes. This study will compare Active Start Active Future, a participation-focused intervention, to usual care in a mixed-methods randomised waitlist-controlled trial.

Methods and analysis: A total of 40 children with CP (3-7 years), classified in Gross Motor Function Classification System (GMFCS) levels II-V, will be stratified (GMFCS II vs III, IV vs V) and randomised to receive either (1) Active Start Active Future, an 8-week intervention for 1 hour per week in any setting or (2) usual care followed by delayed intervention. Active Start Active Future aims to increase PA and reduce sedentary behaviour of young children with CP by providing participatory opportunities to promote PA behaviour change. Outcomes will be measured at baseline (T1), immediately postintervention at 8 weeks (T2) and at 26 weeks postbaseline (T3). The primary outcomes are the Canadian Occupational Performance Measure for both child and parent participation goals and child physical performance goal. Secondary outcomes include daily time spent in moderate to vigorous PA and sedentary time, gross motor function, quality of life, barriers to participation for the children and parents' PA and sedentary time. Intervention acceptability and experiences of PA participation will be explored using a qualitative descriptive approach.

Ethics and dissemination: The Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/23/QCHQ/100850) and The University of Queensland Human Research Ethics Committee (2024/HE000054) have approved this study. The results of the study will be disseminated to families and community agencies as guided by our advisory group and as conference abstracts and presentations, peer-reviewed articles in scientific journals and institution newsletters and media releases.

Trial registration number: ACTRN12624000042549, Universal Trial Number: U1111-1300-7421; Australian New Zealand Clinical Trials Registry.

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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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