Benton Madeleine, Iman Iklil, Goldsmith Kimberley, Forbes Angus, Ching Siew Mooi, Papachristou Nadal Iliatha, Guess Nicola, Murphy Helen R, Mohd Yusof Barakatun-Nisak, Baharom Anisah, Mahamad Sobri Nur Hafizah, Basri Nurul Iftida, Salim Mazatulfazura Sf, Ismail Irmi Zarina, Hassan Faezah, Ismail Khalida, Chew Boon How
Department of Psychological Medicine, King's College London, London, United Kingdom.
Department of Family Medicine, Universiti Putra Malaysia, Selangor, Malaysia.
JMIR Res Protoc. 2022 Sep 8;11(9):e37288. doi: 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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.
有妊娠期糖尿病（GDM）病史的女性中，超过50%在日后会发展为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的风险更高。生活方式干预和行为改变可以延缓甚至预防T2D的发病。我们开发了一种数字化糖尿病预防干预措施，用于预防患有GDM的马来西亚女性患T2D。
该方案描述了一项随机对照试验（RCT），以测试进行糖尿病预防干预的确定性试验的可行性，包括一款智能手机应用程序和团体支持。次要目标是总体上以及按分配组总结人体测量学、生物医学、心理和生活方式方面的结果，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名患有GDM的马来西亚女性将在孕期被随机分组，接受干预或标准护理，直至产后12个月。干预措施是一种糖尿病预防干预，通过一款基于信息-动机-行为技能行为改变模型开发的智能手机应用程序以及使用动机性访谈的团体支持来实施。该干预为女性提供量身定制的信息和支持，以通过调整饮食摄入和体育活动来鼓励减肥。对照组的女性将接受标准护理。马来西亚卫生部医学研究与伦理委员会已批准该试验（NMRR-21-1667-60212）。
招募工作于2022年2月开始。未来的结果将发表在同行评审的健康相关研究期刊上，并在国家、地区或州级专业会议上展示。本出版物基于2022年1月19日的方案版本2。
据我们所知，这将是马来西亚第一项旨在确定对患有GDM的女性进行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参考。
ClinicalTrials.gov NCT05204706；https://clinicaltrials.gov/ct2/show/NCT05204706。
国际注册报告识别码（IRRID）：PRR1-10.2196/37288。
