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Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou I, Guess N, Murphy HR, Mohd Yusof BN, Baharom A, Mahamad Sobri NH, Basri NI, Salim MS, Ismail IZ, Hassan F, Ismail K, Chew BH
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 application for the prevention of type 2 diabetes in Malaysian women with gestational diabetes mellitus: a protocol for a feasibility randomized controlled trial
Madeleine Benton;
Iklil Iman;
Kimberley Goldsmith;
Angus Forbes;
Siew Mooi Ching;
Iliatha Papachristou;
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
ABSTRACT
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 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 application 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. Sixty Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months postpartum. The intervention is a diabetes prevention intervention delivered via a smartphone application developed based on the Information-Motivation-Behavioral Skills (IMB) model of behavior change and group support utilizing 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.
Results:
The Malaysian Ministry of Health’s Medical Research and Ethics Committee (MREC) have approved the trial (NMRR-21-1667-60212). Recruitment and enrolment will begin in February 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. Clinical Trial: ClinicalTrials.gov NCT05204706
Citation
Please cite as:
Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou I, Guess N, Murphy HR, Mohd Yusof BN, Baharom A, Mahamad Sobri NH, Basri NI, Salim MS, Ismail IZ, Hassan F, Ismail K, Chew BH
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