Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial.
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial.
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DOI：
10.1136/bmjopen-2021-052563
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发表时间：
2021-11-26
期刊：
影响因子：
2.9
通讯作者：
Cocks M
中科院分区：
文献类型：
--
作者：
Hesketh K;Low J;Andrews R;Jones CA;Jones H;Jung ME;Little J;Mateus C;Pulsford R;Singer J;Sprung VS;McManus AM;Cocks M
运动和体力活动（PA）是治疗2型糖尿病的基础。对于新诊断的2型糖尿病患者，目前的运动和PA策略在临床上有效，但不适合常规实践（监督运动），或适合常规实践但临床无效（PA建议）。移动的健康（mHealth）技术为患者和医疗保健专业人员提供生物特征数据，可以弥合监督锻炼和PA建议之间的差距，使患者能够参与定期的长期身体活动的生活方式。这项可行性随机对照试验（RCT）将评估在最近诊断为2型糖尿病的患者中，将mHealth技术纳入结构化的家庭运动和PA干预时的使用。这项可行性多中心、平行组RCT将在英国（n=60）和加拿大（n= 60）招募120名2型糖尿病患者（诊断时间为5-24个月，年龄为40-75岁）。参与者将进行为期6个月的结构化运动和PA干预，并由运动专家（主动控制）提供支持。干预组将获得智能手表和手机应用程序的额外支持，提供实时反馈，并改善运动专家和参与者之间的沟通。主要结果是招募率，坚持锻炼和失访。次要结局包括定性过程评价和未来RCT潜在临床结局指标的试点。该试验在英国获得了东南苏格兰研究伦理委员会01（20/SS/0101）的批准，在加拿大获得了不列颠哥伦比亚省临床研究伦理委员会（H20-01936）的批准，并按照赫尔辛基宣言和药物临床试验质量管理规范进行。研究结果将发表在同行评审的期刊上，并在国家和国际科学会议上发表。ISRCTN14335124; ClinicalTrials.gov：NCT04653532。
Exercise and physical activity (PA) are fundamental to the treatment of type 2 diabetes. Current exercise and PA strategies for newly diagnosed individuals with type 2 diabetes are either clinically effective but unsuitable in routine practice (supervised exercise) or suitable in routine practice but clinically ineffective (PA advice). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and PA advice, enabling patients to engage in regular long-term physically active lifestyles. This feasibility randomised controlled trial (RCT) will evaluate the use of mHealth technology when incorporated into a structured home-based exercise and PA intervention, in those recently diagnosed with type 2 diabetes. This feasibility multicentre, parallel group RCT will recruit 120 individuals with type 2 diabetes (diagnosis within 5–24 months, aged 40–75 years) in the UK (n=60) and Canada (n=60). Participants will undertake a 6-month structured exercise and PA intervention and be supported by an exercise specialist (active control). The intervention group will receive additional support from a smartwatch and phone app, providing real-time feedback and enabling improved communication between the exercise specialist and participant. Primary outcomes are recruitment rate, adherence to exercise and loss to follow-up. Secondary outcomes include a qualitative process evaluation and piloting of potential clinical outcome measures for a future RCT. The trial was approved in the UK by the South East Scotland Research Ethics Committee 01 (20/SS/0101) and in Canada by the Clinical Research Ethics Board of the University of British Columbia (H20-01936), and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings. ISRCTN14335124; ClinicalTrials.gov: NCT04653532.
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DOI：
10.1186/s13012-017-0605-9
发表时间：
2017-06-21
期刊：
Implementation science : IS
影响因子：
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作者：
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期刊：
Implementation science : IS
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