Gestational diabetes mellitus (GDM) is a global health challenge, with rates increasing
around the world. The adverse short and long-term health outcomes of GDM for both mother and
their offspring have been well established. In the long-terms women are up to ten times more
likely to develop T2D after GDM and approximately 50% of mothers with GDM will develop
diabetes within 10 years. Considerable evidence from several landmark studies has shown that
healthy lifestyle interventions and behaviour change can delay or even prevent the onset of
T2D in high-risk populations. Given women with prior GDM are at high risk of developing T2D
earlier in their lifespan than women with normoglycemic pregnancies, intervening early with
an effective diabetes prevention intervention offers a unique window of opportunity along the
life-course for the prevention of T2D for the mother. Mobile health (mHealth) is a rapidly
growing field of public health, defined as the use of mobile phones and other wireless
technology to support the achievement of health objectives. Due to the increasing ownership
rate of smartphones, significant numbers of mHealth applications 'apps' have been developed.
Pregnant and postpartum women are increasingly utilising such technologies as sources of
health information and services for pregnancy self-care and infant care.
The overall aim of the RCT is to test the feasibility of undertaking a definitive trial of a
diabetes prevention intervention delivered via a smartphone app over 15-months in women with
GDM from randomisation in the antenatal period to 12 months postpartum.
Sixty participants will be recruited from three public health clinics within the southern
Selangor state of Malaysia. Women will be eligible for recruitment if they meet the following
criteria: i) aged above 18 years, ii) diagnosed with GDM defined using fasting blood glucose
> 5.1mmol/1 or 2-hour postprandial >7.8mmol/1 which are the standard guidelines for diagnosis
of GDM in Malaysia, iii) permanent resident in the state of Selangor, iv) registered in one
of the study health clinics v) owning a smartphone (iOS 11 or Android 7), vi) able to speak,
read, and understand English and/or Malay. Women will be excluded if they meet any of the
following criteria: i) are having a twin pregnancy, ii) have type 1 or 2 diabetes, iii) have
severe physical disability that would prevent any increased uptake of physical exercise, iv)
have severe mental illness (psychosis, bipolar, substance dependence or active suicidal
ideation), v) are currently participating in a weight loss program or diabetes prevention
intervention.
Women who meet study inclusion criteria and consent to study participation will be randomised
to either the intervention or control arm. The intervention consists of a smartphone app for
women with GDM called MyManis (the English meaning of MyManis is 'my sweet (baby)' and a
virtual peer support group. The development of the app was guided by the
Information-Motivation-Behavioural Skills (IMB) model of behaviour change. The MyManis app
aims to provide women with information and support and motivation to act on this information
to make lifestyle behaviour changes in diet and physical activity from pregnancy to
post-partum. The app is available for women in both Malay and English. Women allocated to the
control arm will receive standard care and no digital intervention.
The overall aim of the RCT is to test the feasibility of undertaking a definitive trial of a
diabetes prevention intervention including a smartphone app and group support over 15-months
in women with GDM from randomization in the antenatal period to 12 months postpartum.