《Let's Grow 随机对照试验方案：评估移动健康干预对幼儿运动行为的疗效、成本效益和可扩展性》
Protocol for the Let's Grow randomised controlled trial: examining efficacy, cost-effectiveness and scalability of a m-Health intervention for movement behaviours in toddlers.
机构信息
Institute for Physical Activity and Nutrition, Deakin University Faculty of Health, Geelong, Victoria, Australia
Institute for Physical Activity and Nutrition, Deakin University Faculty of Health, Geelong, Victoria, Australia.
出版信息
BMJ Open. 2022 Mar 28;12(3):e057521. doi: 10.1136/bmjopen-2021-057521.
INTRODUCTION
Despite being an important period for the development of movement behaviours (physical activity, sedentary behaviour and sleep), few interventions commencing prior to preschool have been trialled. The primary aim of this trial is to assess the 12-month efficacy of the mHealth intervention, designed to improve the composition of movement behaviours in children from 2 years of age. is novel in considering composition of movement behaviours as the primary outcome, using non-linear dynamical approaches for intervention delivery, and incorporating planning for real-world implementation and scale-up from its inception.
METHODS AND ANALYSIS
A randomised controlled trial will test the effects of the 12-month parental support mHealth intervention, , compared with a control group that will receive usual care plus electronic newsletters on unrelated topics for cohort retention. will be delivered via a purpose-designed mobile web application with linked SMS notifications. Intervention content includes general and movement-behaviour specific parenting advice and incorporates established behaviour change techniques. Intervention adherence will be monitored by app usage data. Data will be collected from participants using 24-hour monitoring of movement behaviours and parent report at baseline (T), mid-intervention (T; 6 months post baseline), at intervention conclusion (T; 12 months post baseline) and 1-year post intervention (T; 2 years post baseline). The trial aims to recruit 1100 families from across Australia during 2021. In addition to assessment of efficacy, an economic evaluation and prospective scalability evaluation will be conducted.
ETHICS AND DISSEMINATION
The study was approved by the Deakin University Human Ethics Committee (2020-077). Study findings will be disseminated through publication in peer-reviewed journals, presentation at scientific and professional conferences, and via social and traditional media.
TRIAL REGISTRATION NUMBER
ACTRN12620001280998; U1111-1252-0599.
简介
尽管这是发展运动行为（体力活动、久坐行为和睡眠）的重要时期，但很少有干预措施在学前开始进行试验。本试验的主要目的是评估 mHealth 干预措施在 2 岁儿童中改善运动行为组成的 12 个月疗效。该研究的新颖之处在于将运动行为组成作为主要结果，使用非线性动力方法进行干预交付，并从一开始就纳入了现实世界实施和扩大规模的规划。
方法和分析
一项随机对照试验将测试为期 12 个月的父母支持 mHealth 干预措施的效果，与对照组进行比较，对照组将接受与运动行为无关的主题的电子通讯，以保持队列。将通过专门设计的移动网络应用程序与链接的 SMS 通知来提供干预措施。干预内容包括一般和运动行为特定的育儿建议，并结合了已建立的行为改变技术。通过应用程序使用数据监测干预依从性。将通过 24 小时监测运动行为和父母报告来从参与者那里收集数据，基线（T）、中期干预（T；基线后 6 个月）、干预结束时（T；基线后 12 个月）和干预后 1 年（T；基线后 2 年）。该试验旨在 2021 年期间从澳大利亚各地招募 1100 个家庭。除了评估疗效外，还将进行经济评估和前瞻性可扩展性评估。
伦理和传播
该研究得到了迪肯大学人类伦理委员会的批准（2020-077）。研究结果将通过发表在同行评议的期刊上、在科学和专业会议上的报告以及通过社交媒体和传统媒体进行传播。
试验注册号
ACTRN12620001280998；U1111-1252-0599。
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