A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.
A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.
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用于预防马来西亚妊娠糖尿病女性 2 型糖尿病的手机应用程序：可行性随机对照试验方案。
DOI：
10.2196/37288
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发表时间：
2022-09-08
影响因子：
1.7
通讯作者：
Chew, Boon How
中科院分区：
文献类型：
--
作者：
Benton, Madeleine;Iman, Iklil;Goldsmith, Kimberley;Forbes, Angus;Ching, Siew Mooi;Nadal, Iliatha Papachristou;Guess, Nicola;Murphy, Helen R.;Yusof, Barakatun-Nisak Mohd;Baharom, Anisah;Sobri, Nur Hafizah Mahamad;Basri, Nurul Iftida;Salim, Mazatulfazura Sf;Ismail, Irmi Zarina;Hassan, Faezah;Ismail, Khalida;Chew, Boon How
超过50%有妊娠期糖尿病（GDM）病史的女性会在以后的生活中发展为2型糖尿病（T2D）。与其他种族背景的女性相比，亚洲女性患GDM和T2D的风险不成比例。生活方式干预和行为改变可以延缓甚至预防糖尿病的发生。我们已经开发了一种数字化的糖尿病预防干预措施，用于预防马来西亚女性糖尿病患者的T2D。该方案描述了一项随机对照试验（RCT），以测试开展糖尿病预防干预的最终试验的可行性，包括智能手机应用程序和小组支持。次要目的是总结人体测量学、生物医学、心理和生活方式的总体和分配组结果，并进行过程评估。这是一项双臂平行可行性随机对照试验。共有60名马来西亚GDM妇女将在产前随机接受干预或标准护理，直到产后12个月。干预是通过智能手机应用程序提供的糖尿病预防干预，该应用程序基于行为改变的信息-动机-行为技能模型和使用动机访谈的群体支持。干预措施为妇女提供量身定制的信息和支持，鼓励她们通过适当的饮食摄入和体育活动来减肥。对照组的妇女将接受标准治疗。马来西亚卫生部医学研究和伦理委员会已批准该试验（NMRR-21-1667-60212）。招聘和入学于2022年2月开始。未来的结果将发表在同行评议的健康相关研究期刊上，并在国家、地区或州的专业会议和会议上发表。本出版物基于2022年1月19日的协议版本2。据我们所知，这将是马来西亚第一项旨在确定GDM女性T2D预防数字干预可行性的研究。这项可行性研究的结果将为未来全面随机对照试验的设计提供信息。ClinicalTrials.gov NCT05204706;https://clinicaltrials.gov/ct2/show/NCT05204706 prr1 - 10.2196/37288
Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM. The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation. This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health’s Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212). Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022. To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future. ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706 PRR1-10.2196/37288
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影响因子：
158.5
作者：
Knowler, WC;Barrett-Connor, E;Nathan, DM
通讯作者：
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