The Malaysian GestatiOnal Diabetes and prevention of DiabetES Study (MY GODDESS)
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.
Aims
The overall aim is to develop and test the feasibility of a novel interactive culturally appropriate digitalised DPI specific for GDM.
Methods
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.
Workstream 2: we will conduct an RCT comparing the DPI with usual care for 12 months for 60 women with current GDM to assess the feasibility of conducting a future full scale definitive effectiveness RCT (study 2).
Work that has informed The Malaysian GestatiOnal Diabetes and prevention of DiabetES Study (MY GODDESS) includes:
Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou 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 application for the prevention of type 2 diabetes in Malaysian women with gestational diabetes mellitus: a protocol for a feasibility randomized controlled trial. JMIR Research Protocols. 26/04/2022:37288 (forthcoming/in press)
Sobri NHM, Ismail IZ, Hassan F On behalf of the MYGODDESS Project Team, et al. 2021. 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. doi: 10.1136/bmjopen-2020-044878
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. doi.org/10.1177/16094069211034010
Work that has informed The Malaysian GestatiOnal Diabetes and prevention of DiabetES Study (MY GODDESS) includes:
Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou 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 application for the prevention of type 2 diabetes in Malaysian women with gestational diabetes mellitus: a protocol for a feasibility randomized controlled trial. JMIR Research Protocols. 26/04/2022:37288 (forthcoming/in press)
Sobri NHM, Ismail IZ, Hassan F On behalf of the MYGODDESS Project Team, et al. 2021. 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. doi: 10.1136/bmjopen-2020-044878
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. doi.org/10.1177/16094069211034010
Principal Investigator
Khalida Ismail
Professor of Psychiatry & Medicine