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

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.

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).

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.