The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study (MyGODDESS)

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.

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.

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.

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.

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.

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.

The proportion of women who were randomised (numerator) out of those identified from the clinical registers (study population as denominator)

The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)

The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)

The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)

The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

The proportion of women who give consent for screening eligibility (numerator) out of those identified from clinical registers (denominator)

The proportion of women who were randomised (numerator) out of those eligible to participate (denominator)

The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)

The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)

The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)

The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)

The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)

This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.

This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.

This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.

The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.

The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.

The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.

The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.

The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.

The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.

The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.

The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.

The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.

The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.

The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.

The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.

Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.

Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.

Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.

This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)

This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)

This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)

This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.

This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.

This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.

This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.

This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.

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.

Mohd Sa'id, I. I., Papachristou Nadal, I., Forbes, A., Goldsmith, K., Ismail, I. Z., Hassan, F., Ching, S. M., Guess, N., Murphy, H., Prina, M., Mohd Yusoff, B. N., Basri, N. I., Binti Salim, M. S., Mahamad Sobri, N. H., Har Yap, P. P., Ismail, K., & Chew, B. H. (2021). A Protocol of Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: A Systematic Review. International Journal of Qualitative Methods, 20. https://doi.org/10.1177/16094069211034010

Sobri NHM, Ismail IZ, Hassan F, Papachristou Nadal I, Forbes A, Ching SM, Ali H, Goldsmith K, Murphy H, Guess N, Mohd Yusof BN, Basri NI, Salim MS, Azmiyaty C, Mohd Sa'id II, Chew BH, Ismail K; MYGODDESS Project Team. Protocol for a qualitative study exploring the perception of need, importance and acceptability of a digital diabetes prevention intervention for women with gestational diabetes mellitus during and after pregnancy in Malaysia (Explore-MYGODDESS). BMJ Open. 2021 Aug 26;11(8):e044878. doi: 10.1136/bmjopen-2020-044878.

Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou Nadal 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. JMIR Res Protoc. 2022 Sep 8;11(9):e37288. doi: 10.2196/37288.