The Malaysian GestatiOnal Diabetes and prevention of DiabtES Study (MY GODDESS)

Lead Research Organisation: King's College London
Department Name: Psychological Medicine

Abstract

Gestational diabetes is a condition that occurs during pregnancy when the blood sugar is higher than it should be. After the baby is born, the blood sugar returns to normal. The number of women in Malaysia that develop gestational diabetes is about 50,000 each year and these numbers are increasing with the worldwide epidemic of obesity. Around half od the women with gestational diabetes are likely to develop either type 2 diabetes or pre diabetes within 10 years. In other words, these women who are child-rearing and who may also be working outside the home, are developing diabetes in their 30s and 40s, almost 20 years before the average person. Gestational diabetes leads to further health problems and the baby can be born big-for-dates which increases his/her chances of developing type 2 diabetes later in life. Malays, Indian and Chinese Malaysians are all at high risk for getting diabetes.

The chances of getting type 2 diabetes could be significantly reduced if women made lifestyle changes to lose weight and increase their physical activity. This can be very difficult with modern lifesyles and demands. Also getting gestational diabetes is usually a very upsetting experience because the mother feels guilty and also worrying about the health of her baby. There have been trials, mainly in North America, testing different types of lifestlyes but the findings from these trials are not clear cut. There have been no trials reported in Malaysia. We still do not know what kind of support women would find the most helpful.

King's Health Partners has one of the largest clinical and research units for diabetes. We have been developing new approaches to supporting women with gestational diabetes (led by Prof Angus Forbes and Pro Helen Murphy). Our interviews with women with gestational diabetes showed that women in the UK have a poor understanding of their risk of developing diabetes and we think this might be the same for women in Malaysia. They also did not know how best to lower their risk and worried that exercise and different diet might harm their baby. We also found that women became very upset, guilty and burdened after they were told they had gestational diabetes.

This project is called MY GODDESS and we aim to share the ideas and experiences of women in the UK and Malaysia. In the first set of studies, we will review the research already published and find out what works and what doesn't. We will focus on studies that uses digital technology such as apps, websites from the smartphone or computer. We will then interview women with a history of gestational diabetes and ask what was difficult about making lifestyle changes and what helped. We will then use use our shared knowledge as researchers and as patients to design a new treatment to support lifestyle change. We will consider ideas such as group sessions, lifestyle coaches text messages, and wearing devices that measure our step counts and heart rate. We will develop the MY GODDESS app which can be downloaded onto a smartphone. We believe that if we understand better how to harness the 'health power' in digital technology, we will produce stronger support systems to help women with GDM lead healthier lifestyles.

The second project is to test our new treatment, MY GODDESS, in a small study to see if we could test our new could be conducted at a largerthat it does help women to make lifestyle changes. We will recruit about 50 patients. We will study how many women we could identify, who will be interested in participating and who will stay in the treatment to the end. We will ask women for feedback about their experience, what worked and what did not and any suggestions about improvement.

By the end of the project if our findings are in the right direction, we will submit a proposal to conduct a full scale trial to test whether MY GODDESS works in a much larger sample of women across Malaysia.

Technical Summary

Nearly 20% of women in Malaysia develop gestational diabetes mellitus (GDM). Recent international findings report that around half of women with GDM are likely to develop (T2D) or prediabetes within 10 years. Despite many randomised controlled trials (RCT) of diabetes prevention interventions (DPI) in GDM the effectiveness of DPIs remains unclear. There is no evidence base for the most effective DPI for GDM in Malaysia. We propose to use the MRC complex interventions framework to address this major deficit in evidence. The overall aim is to develop and test the feasibility of a novel interactive culturally appropriate digitalised DPI specific for GDM. In workstream 1 (development phase) we will conduct a literature review of the process evaluations of RCTs of digitalised DPIs in GDM to identify implementation, mechanisms of action and contextual factors important in optimising effectiveness (study 1a). In parallel we will conduct a focus group with women with GDM and health care professionals to understand the barriers and facilitators of uptake of DPI, and solutions to optimise the DPI (study 1b). We will integrate these findings to develop a logic model of our digitalised DPI and use participatory learning and action methods to finalise the intervention including the contents of the DPI app (studies 1c & 1d). The key components of the DPI proposed are: initial face-to-face group session; online educational diabetes prevention curriculum appropriate for Malaysian culture; biofeedback of physical activity, diet and emotions levels; motivational SMS messages; chat function for women to communicate with each other; facilitation by a dietician trained in behaviour change techniques and supportive counselling; a manual. In workstream 2, we will conduct an RCT comparing the DPI with usual care for 12 months for 50 women with current GDM to assess the feasibility of conducting a future full scale definitive effectiveness RCT (study 2).

Planned Impact

We aim to deliver our impact for clinical and academic benefit; to patient groups; and for cultural and educational benefits to the public and schoolchildren, in the UK, Malaysia and worldwide. Specifically our pathways include:

1. Peer review dissemination: we will submit to appropriate and high-impact journals, and present at international conferences, such as the International Federation of Diabetes, the American Association for Diabetes, Diabetes UK. This will lead to increased opportunities for future collaborations and grant funding.

2. Translation into national policy: in the UK, the NHS Diabetes Prevention Programme does not include women with a history of GDM. We may therefore (based on our findings) recommend changes to, or integration with, the NHS Diabetes Prevention Program to ensure women with a history of GDM are also referred to lifestyle change. In Malaysia, the latest Malaysia Perinatal Guidelines 3rd edition do not include any extensive reference to supporting and motivational women with GDM to make lifestyle changes either. We will send our findings to the Guidelines committee for inclusion.

3. Translation into clinical service: the strength of an Academic Health Science Centre is that it is vehicle for translating research into clinical practice quickly. The UK PI (Ismail) has demonstrated impact of research by developing multi-award winning service innovation (3 Dimensions for Diabetes) following a Wellcome Trust funded cohort study that showed that depression was associated with increased risk of mortality.

4. Training in complex interventions in developing nations: we will set up a joint KCL-UPM 2-day course on mixed methods for developing and evaluating prevention of NCDs in Malaysia.

5. International networks: we will use our collective experience of this project to develop collaborations across other developing nations. For instance, we have collaborations set up in Sri Lanka and Kuwait.

6. Ambassadors: senior UK and Malaysia investigators, (Forbes, Ismail, Murphy, Mohd Yosuf) are internationally recognised in their field and will have a role in networking and branding.

7. Knowledge transfer: as part of our knowledge transfer during our exchange trips (at least two per UK investigator planned) we will supervise as required to implement the science into clinical practice into Malaysia. We will also offer a mentoring programme for rising stars in UPM. We will offer KCL honorary contracts to the Malaysia investigators to benefit from the range of e learning resources within the university.

8. Social media: we intend to have a blog that will be led by the project managers as an account of the shared cultural experience but also for dissemination eg advertising successes, publications and conferences.

9. Behaviour change techniques training: we will extend these academic and clinical skills by training and capacity building of healthcare workers in Malaysia.

10. Working with patient groups: by staging events with charities and third sector groups in the UK such as Tommy's Charity and Diabetes UK, and their equivalents in Malaysia, Ibu Family Resource Group and Baby Center Malaysia, and Malaysia Diabetes (equivalent to Diabetes UK) we will increase awareness.

11. We will also ensure our study has educational, cultural and societal impact by reaching out to local schools to talk about the study within current outreach initiatives run by KCL, and by sessions organised by the team in Malaysia.
 
Description Motivational Interview Training for 2 PhD students in Malaysia
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Motivational Interview Training has built capacity in practice and research for two dietitians in Malaysia also undertaking their PhD.
 
Description Commenwealth Split Site Scholarship
Amount £17,719 (GBP)
Organisation Foreign Commonwealth and Development Office (FCDO) 
Sector Public
Country United Kingdom
Start 02/2022 
End 02/2023
 
Description Hospital Putrajaya and Health Clinics collaborations 
Organisation Putrajaya Holdings Sdn. Bhd.
Country Malaysia 
Sector Private 
PI Contribution The team are working in partnership with the hospital and 5 health clinics to recruit participants, review specific clinical data needed and set up patient an public involvement groups.
Collaborator Contribution Lead clinicians from these clinics are working with the research team to accommodated our specific milestones.
Impact Conversations for implementing the outputs from this project with be made once tools are complete.
Start Year 2019
 
Description Lava X Technologies 
Organisation Lava X Technologies
Country Malaysia 
Sector Private 
PI Contribution Lava X Technologies is involved in the developed of the mobile phone application for the development of the diabetes prevention intervention.
Collaborator Contribution Lava X Technologies have been developing the mobile phone application in consolation with the study team.
Impact The mobile application is still in development phase - a mock up of the application has been produced.
Start Year 2020
 
Description MSc and PhD students working in partnership on the project 
Organisation Putra Malaysia University
Country Malaysia 
Sector Academic/University 
PI Contribution The research team provide weekly supervision and work with the students to produce quality publishable work. We provide them with the opportunity to lead on manuscripts for peer review journals.
Collaborator Contribution The students have been responsible for conducting a literature review, interviewing participants for qualitative components of the project, and conducting patient and public involvement workshops.
Impact Our students are leading on at least one publication each.
Start Year 2020
 
Description Mobile phone application development 
Organisation Putra Malaysia University
Country Malaysia 
Sector Academic/University 
PI Contribution The MyGoddess has collaborated with Associate Professor Koh Tieng Wei in the development of the MyManis mobile phone application (the intervention of the current RCT). This collaboration involved application specification, guiding documents, and back-end development alongside LAVA-X.
Collaborator Contribution Koh Tieng Wei is Associate Professor in the Faculty of Computer Science and Information Technology at the University Putra Malaysia. Prof Koh has assisted with several technical aspects of the mobile application development including back-end specification.
Impact In collaboration with Prof Koh and the MyGoddess team we are currently writing a publication outlining the development stages of the mobile application.
Start Year 2021
 
Description Project's systematic review 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution A systematic review expert from King's College London, independent from the research team has been collaborating with the UK and Malaysian team to develop the systematic review protocol and search strategy. The research team have been leading on the writing and developed the manuscript for submission to a peer review journal. Research team are currently extracting and analysis the data.
Collaborator Contribution Dr Mathew Prina, a senior lecturer from King's has been advising on the review, developing the search strategy and overseeing the process. He has been involved on developing the manuscript and is co author for the peer review publication.
Impact 1. Systematic review protocol under peer review with BMC Systematic Reviews 2. Registered Systematic review onto PROSPERO
Start Year 2019
 
Title Diabetes prevention intervention - mobile app 
Description A mobile application (diabetes prevention intervention) which is being tested in the feasibility trial is currently under development. 
Type Of Technology Webtool/Application 
Year Produced 2021 
Impact The mobile application is currently in its development phase and therefore has not been completed. 
 
Description Exercise during pregnancy: Why and how? 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Medical and nutritional experts from our research team led on a series of webinars discussing physical activity during pregnancy. This was very well received from over 100 participants. We received positive written feedback on completion.
Year(s) Of Engagement Activity 2020
 
Description Patient and public involvement interviews 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact A PPI activity was conducted using one UK based person who has experience with gestational diabetes. Here, the researcher used the proposed topic guide for the main qualitative study. As a result the topic guide was edited and views and experience of the participant was gained.
Year(s) Of Engagement Activity 2020
 
Description Qualitative research and review methods webinar 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Over 100 participants attended an online series of webinars - Topics included - introduction to qualitative research methods; process evaluation of complex interventions; qualitative data collection and management and qualitative review met synthesis methods.

Both UK and Malaysian team members lead on these webinar. They were well attended and reviewed positive written feedback.
Year(s) Of Engagement Activity 2020
 
Description Webinar on gestational diabetes mellites 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Obstetric and gynaecology experts provided a one off webinar to a Malaysia and UK audience. Up to 100 people participated. This included academics, health professionals as well as post grad students. We received positive written feedback on completion.
Year(s) Of Engagement Activity 2020
 
Description Working patient and public involvement group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Patients, carers and/or patient groups
Results and Impact We are actively working with a small group of Malaysian women who have or who have had gestational diabetes. These women form part of our PPI group, where we share working protocols, and further research developments that arise from our project.
Year(s) Of Engagement Activity 2020,2021