The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study

Study Overview
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Brief Summary
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Gestational diabetes mellitus (GDM) is an increasingly common condition of pregnancy and is associated with adverse foetal, infant, and maternal outcomes. Over 50% of women with history of 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 groups. Lifestyle interventions have been proven to be effective in preventing progression to T2DM in high-risk populations. This is a two-arm, parallel feasibility RCT. Sixty Malaysian women with GDM will be randomized to receive the intervention or standard care in the antenatal period to 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, which will provide 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.

Detailed Description
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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.

Official Title
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A Feasibility Randomised Controlled Trial of a Mobile Phone Application for the Primary Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus.

Conditions
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Gestational Diabetes, GDM, Pregnancy-Induced Diabetes

Intervention / Treatment
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* Other: MyManis app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged above 18 years, 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, permanent resident in the state of Selangor, registered in one of the study health clinics owning a smartphone (iOS 11 or Android 7) with internet connection, able to speak, read, and understand English and/or Malay. Exclusion Criteria: are having a twin pregnancy, have type 1 or 2 diabetes, have severe physical disability that would prevent any increased uptake of physical exercise, have severe mental illness (psychosis, bipolar, substance dependence or active suicidal ideation), are currently participating in a weight loss program or diabetes prevention intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>Women who meet study inclusion criteria and consent to study participation will be randomised using sealed envelope randomisation and online database for clinical trials to one of two groups in a 1:1 ratio. | Other: MyManis app<br>* The women will receive a brochure outlining the app features and step guide on how to download the app which will be available in both Bahasa Melayu and English languages. A link to download the app via text message will also be sent to participants for convenience. Once the app has been downloaded, participants will be invited to set up an account. Once completed this will give them full access to the MyManis app. The key component of MyManis app content presented under six main tabs which are homepage, information, diet, exercise, wellbeing and GDM monitoring. The women will be invited to join group peer support through WhatsApp facilitated by a dietitian trained in motivational interviewing. The women will be notified via text message if an update of the app is required. If there's women who have not accessed the app for over a two-week period will be flagged and a notification will be sent via the app to motivate app engagement.<br>|
| No Intervention: Control arm<br>Women allocated to the control arm will receive standard care and no digital intervention. This includes self-monitoring blood glucose and lifestyle advice (diet, physical activity, optimal body weight) by a multidisciplinary team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women who were randomised to the treatment groups. | The proportion of women who were randomised (numerator) out of those identified from the clinical registers (study population as denominator) | Collected antenatally at 30 weeks pregnancy | 
| Number of women that take up the intervention | The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator) | Collected antenatally at 36 weeks pregnancy | 
| Number of women that take up the intervention | The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator) | Collected antenatally at 6 months after delivery. | 
| Number of women that take up the intervention | The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator) | Collected antenatally at 12 months after delivery. | 
| Number of women withdrawn or loss to follow up | The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 36 weeks pregnancy | 
| Number of women withdrawn or loss to follow up | The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 3 months after delivery | 
| Number of women withdrawn or loss to follow up | The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 6 months after delivery | 
| Number of women withdrawn or loss to follow up | The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 9 months after delivery | 
| Number of women withdrawn or loss to follow up | The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 12 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women consented | The proportion of women who give consent for screening eligibility (numerator) out of those identified from clinical registers (denominator) | Collected antenatally at 24-28 weeks pregnancy | 
| Number of women randomised | The proportion of women who were randomised (numerator) out of those eligible to participate (denominator) | Collected antenatally at 24-28 weeks pregnancy | 
| Number of women completed the secondary outcomes | The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 36 weeks pregnancy | 
| Number of women completed the secondary outcomes | The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 3 months after delivery | 
| Number of women completed the secondary outcomes | The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 6 months after delivery | 
| Number of women completed the secondary outcomes | The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 9 months after delivery | 
| Number of women completed the secondary outcomes | The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator) | Collected antenatally at 12 months after delivery | 
| Number of women randomised | The number of women randomised per month overall, and per month per study site. | Collected antenatally at 30 weeks pregnancy |