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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 M 1 , Iman I 2 , Goldsmith K 3 , Forbes A 4 , Ching SM 2 , Papachristou Nadal I 1 Show all authors , Guess N 5 , Murphy HR 6 , Mohd Yusof BN 7 , Baharom A 8 , Mahamad Sobri NH 2 , Basri NI 9 , Salim MS 10 , Ismail IZ 2 , Hassan F 2 , Ismail K 1 , Chew BH 2

Affiliations 

  • 1 Department of Psychological Medicine, King's College London, London, United Kingdom
  • 2 Department of Family Medicine, Universiti Putra Malaysia, Selangor, Malaysia
  • 3 Department of Biostatistics & Health Informatics, King's College London, London, United Kingdom
  • 4 Division of Care in Long-term Conditions, King's College London, London, United Kingdom
  • 5 Research Centre for Optimal Health, University of Westminster, London, United Kingdom
  • 6 Department of Medicine, University of East Anglia, Norfolk, United Kingdom
  • 7 Department of Nutrition and Dietetics, Universiti Putra Malaysia, Selangor, Malaysia
  • 8 Department of Community Health, Universiti Putra Malaysia, Selangor, Malaysia
  • 9 Department of Obstetrics and Gynaecology, Universiti Putra Malaysia, Selangor, Malaysia
  • 10 Department of Rehabilitation Medicine, Universiti Putra Malaysia, Selangor, Malaysia
JMIR Res Protoc, 2022 Sep 08;11(9):e37288.
PMID: 36074545 DOI: 10.2196/37288

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 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.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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