TY - JOUR
T1 - A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women with Gestational Diabetes Mellitus
T2 - Protocol for a Feasibility Randomized Controlled Trial
AU - Benton, Madeleine
AU - Mohd Sa'Id, Iklil Iman
AU - Goldsmith, Kimberley
AU - Forbes, Angus
AU - Ching, Siew Mooi
AU - Papachristou Nadal, Iliatha
AU - Guess, Nicola
AU - Murphy, Helen R.
AU - Mohd Yusof, Barakatun Nisak
AU - Mahamad Sobri, Nur Hafizah
AU - Basri, Nurul Iftida
AU - Ismail, Irmi Zarina
AU - Hassan, Faezah
AU - Ismail, Khalida
AU - Chew, Boon How
N1 - Publisher Copyright:
©Madeleine Benton, Iklil Iman, Kimberley Goldsmith, Angus Forbes, Siew Mooi Ching, Iliatha Papachristou Nadal, Nicola Guess, Helen R Murphy, Barakatun-Nisak Mohd Yusof, Anisah Baharom, Nur Hafizah Mahamad Sobri, Nurul Iftida Basri, Mazatulfazura Sf Salim, Irmi Zarina Ismail, Faezah Hassan, Khalida Ismail, Boon How Chew.
PY - 2022/9/1
Y1 - 2022/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85139023295&partnerID=8YFLogxK
U2 - 10.2196/37288
DO - 10.2196/37288
M3 - Article
SN - 1929-0748
VL - 11
JO - JMIR research protocols
JF - JMIR research protocols
IS - 9
M1 - e37288
ER -
