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 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 have approved the trial (NMRR-21-1667-60212). Recruitment and enrolment begun 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.
CLINICALTRIAL
ClinicalTrials.gov NCT05204706