The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study

NCT05204706 | Unknown DMC

• 1 other identifier: NMRR-21-1667-60212
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Gestational Diabetes; GDM; Pregnancy-Induced Diabetes

Outcome Measures

Primary Outcomes (9)

• Number of women who were randomised to the treatment groups.

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

  Collected antenatally at 30 weeks pregnancy

• Number of women that take up the intervention

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

  Collected antenatally at 36 weeks pregnancy

• Number of women that take up the intervention

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

  Collected antenatally at 6 months after delivery.

• Number of women that take up the intervention

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

  Collected antenatally at 12 months after delivery.

• Number of women withdrawn or loss to follow up

  The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

  Collected antenatally at 36 weeks pregnancy

• Number of women withdrawn or loss to follow up

  The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

  Collected antenatally at 3 months after delivery

• Number of women withdrawn or loss to follow up

  The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

  Collected antenatally at 6 months after delivery

• Number of women withdrawn or loss to follow up

  The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

  Collected antenatally at 9 months after delivery

• Number of women withdrawn or loss to follow up

  The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)

  Collected antenatally at 12 months after delivery

Secondary Outcomes (8)

• Number of women consented

  Collected antenatally at 24-28 weeks pregnancy

• Number of women randomised

  Collected antenatally at 24-28 weeks pregnancy

• Number of women completed the secondary outcomes

  Collected antenatally at 36 weeks pregnancy

• Number of women completed the secondary outcomes

  Collected antenatally at 3 months after delivery

• Number of women completed the secondary outcomes

  Collected antenatally at 6 months after delivery

Other Outcomes (121)

• Body weight at T0

  Collected antenatally at T0: 30 weeks pregnancy

• Body weight at T1

  Collected antenatally at T1: 36 weeks pregnancy

• Body weight at T2

  Collected antenatally at T2: 3 months after delivery

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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.

Other: MyManis app

Control arm

NO INTERVENTION

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.

Interventions

MyManis app 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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only FEMALE.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• King's College London: collaborator
• Ministry of Education, Malaysia: collaborator
• Ministry of Health, Malaysia: collaborator

Study Sites (3)

Klinik Kesihatan Putrajaya Presint 9

Putrajaya, Kuala Lumpur, 62250, Malaysia

RECRUITING

Klinik Kesihatan Puchong Batu 14

Petaling Jaya, Selangor, 47100, Malaysia

RECRUITING

Klinik Kesihatan Seri Kembangan

Seri Kembangan, Selangor, 43300, Malaysia

RECRUITING

Related Publications (3)

• 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

  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.

  PMID: 34446477 BACKGROUND

• 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.

  PMID: 36074545 BACKGROUND

Related Links

• UKRI website about the project

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• BOON HOW CHEW

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• KHALIDA ISMAIL

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BOON HOW CHEW

CONTACT

0126900652; chewboonhow@upm.edu.my

IKLIL IMAN MOHD SA'ID

CONTACT

iklil17493@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: January 24, 2022
• Study Start: January 24, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)