The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study

NCT ID: NCT05204706

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2023-04-30

Brief Summary

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

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.

Conditions

Gestational Diabetes; GDM; Pregnancy-Induced Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention arm

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.

Group Type: ACTIVE_COMPARATOR

MyManis app

Intervention Type: OTHER

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.

Control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MyManis app

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Ministry of Education, Malaysia

OTHER_GOV

Sponsor Role: collaborator

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Boon-How Chew

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BOON HOW CHEW

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

KHALIDA ISMAIL

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Klinik Kesihatan Putrajaya Presint 9

Putrajaya, Kuala Lumpur, Malaysia

Site Status: RECRUITING

Klinik Kesihatan Puchong Batu 14

Petaling Jaya, Selangor, Malaysia

Site Status: RECRUITING

Klinik Kesihatan Seri Kembangan

Seri Kembangan, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

BOON HOW CHEW

Role: CONTACT

chewboonhow@upm.edu.my

0126900652

IKLIL IMAN MOHD SA'ID

Role: CONTACT

iklil17493@gmail.com

Facility Contacts

Wan Noor Azlin

Role: primary

drwanazlin@moh.gov.my

0133932688

Noor Zaehan Hani

Role: backup

zaehanzolkiply@gmail.com

0132726352

Haslinda Hassan

Role: primary

lynn_nidz@yahoo.com.my

0122146257

Atikah Mohamed Basri

Role: backup

0134495057

Ziti Akthar Supian

Role: primary

zitisupian@gmail.com

0136813478

Fadzilah Abd Rahman

Role: backup

0192257783

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 34446477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36074545 (View on PubMed)

Related Links

https://gtr.ukri.org/projects?ref=MR%2FT018240%2F1

UKRI website about the project

Other Identifiers

NMRR-21-1667-60212

Identifier Type: -

Identifier Source: org_study_id