Research Central, Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia
Illawarra Health and Medical Research Institute, Wollongong, New South Wales, Australia.
BMJ Open. 2022 Apr 19;12(4):e054183. doi: 10.1136/bmjopen-2021-054183.
Given the importance of tummy time and the low levels of tummy time reported globally, there is a need for high-quality intervention strategies to promote tummy time. This study describes the protocol of a randomised controlled trial that aims to determine the effectiveness of a multicomponent intervention delivered in postnatal mothers' groups in increasing infant tummy time.
A randomised controlled trial will be conducted. Eligible participants will be mothers and their infants attending postnatal mothers' groups (New South Wales, Australia). Participants will be randomised to participate in either (1) infant tummy time intervention group (practice, education, WhatsApp) plus usual care; or (2) usual care group. Randomisation process and outcome assessors will be blinded. The intervention will comprise an online education and practice session (60 min) and 4 weeks of WhatsApp messaging (standardised, three times per week). Usual care will be attendance at a mothers group once per week for 3 weeks for information and support for ad hoc mother craft activities (standard practice provided by early childhood nurses for this local health district). The primary outcome will be the amount of infant tummy time using the GENEActiv accelerometer and a questionnaire (post intervention). The accelerometer will be worn on the right hip secured by an elastic belt around the waist. Wear and non-wear time will be classified using temperature and z-axis cut points as per previous research. This protocol paper presents the scientific background and proposed methods of the randomised controlled trial. Findings will inform the design of practically based strategies to inform clinicians, educators and parents about infant physical activity.
The University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee approved the study (2020/ETH02970). Dissemination plan is publication, staff training and conference presentations.
Australian New Zealand Clinical Trials Registry ACTRN12621000575831; Pre-results.
鉴于腹部时间的重要性以及全球报告的腹部时间水平较低,因此需要高质量的干预策略来促进腹部时间。本研究描述了一项随机对照试验的方案,该试验旨在确定在产后母亲群体中实施的多组分干预措施在增加婴儿腹部时间方面的有效性。
将进行一项随机对照试验。符合条件的参与者将是参加产后母亲小组(新南威尔士州,澳大利亚)的母亲及其婴儿。参与者将被随机分配到以下两组之一:(1)婴儿腹部时间干预组(练习、教育、WhatsApp)加常规护理;或(2)常规护理组。随机化过程和结果评估者将被蒙蔽。干预措施将包括在线教育和实践课程(60 分钟)以及 4 周的 WhatsApp 消息传递(标准化,每周三次)。常规护理将是每周参加一次母亲小组,以获得有关临时母亲手工艺活动的信息和支持(该当地卫生区为早期儿童护士提供的标准实践)。主要结局将是使用 GENEActiv 加速度计和问卷调查(干预后)的婴儿腹部时间量。加速度计将佩戴在右臀部,腰部用弹性腰带固定。根据以前的研究,使用温度和 z 轴切点对佩戴和不佩戴时间进行分类。本方案论文介绍了随机对照试验的科学背景和拟议方法。研究结果将为制定基于实践的策略提供信息,以便向临床医生、教育工作者和家长提供有关婴儿身体活动的信息。
伍伦贡大学和伊拉瓦拉肖尔黑文地方卫生区健康和医学人类研究伦理委员会批准了该研究(2020/ETH02970)。传播计划包括出版物、员工培训和会议演讲。
澳大利亚新西兰临床试验注册 ACTRN12621000575831;预结果。