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

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 and Chew, Boon How (2022) 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. JMIR Research Protocols, 11 (9). ISSN 1929-0748

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Background: 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. Objective: 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. Methods: 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). Results: 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. Conclusions: 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.

Item Type: Article
Uncontrolled Keywords: diabetes prevention,gestational diabetes mellitus,mobile app,randomized controlled trial,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
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Depositing User: LivePure Connector
Date Deposited: 21 Oct 2022 11:32
Last Modified: 19 Oct 2023 03:27
URI: https://ueaeprints.uea.ac.uk/id/eprint/89259
DOI: 10.2196/37288


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