Gestational DiabetesMyGODDESSNCT05204706
The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study
A study testing MyManis app in people with Gestational Diabetes and GDM, run by Universiti Putra Malaysia at 3 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, GDM, Pregnancy-Induced Diabetes
- What is being tested?
- MyManis app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesMalaysia
- Study dates
- 24 Jan 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
IKLIL IMAN MOHD SA'ID contact
Malaysia3 sites, 3 recruiting
- Recruiting
Klinik Kesihatan Puchong Batu 14
Petaling Jaya, Selangor, 47100
Haslinda Hassan, 0122146257, lynn_nidz@yahoo.com.my
Atikah Mohamed Basri, 0134495057
- Recruiting
Klinik Kesihatan Putrajaya Presint 9
Putrajaya, Kuala Lumpur, 62250
Wan Noor Azlin, 0133932688, drwanazlin@moh.gov.my
Noor Zaehan Hani, 0132726352, zaehanzolkiply@gmail.com
- Recruiting
Klinik Kesihatan Seri Kembangan
Seri Kembangan, Selangor, 43300
Ziti Akthar Supian, 0136813478, zitisupian@gmail.com
Fadzilah Abd Rahman, 0192257783
About this study
Official title: A Feasibility Randomised Controlled Trial of a Mobile Phone Application for the Primary Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus.
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.
Read the 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
- Being tested
- MyManis app
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyManis appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Collected antenatally at 12 months after delivery
Secondary outcomes (8)
Number of women consented
The proportion of women who give consent for screening eligibility (numerator) out of those identified from clinical registers (denominator)
Measured: Collected antenatally at 24-28 weeks pregnancy
Number of women randomised
The proportion of women who were randomised (numerator) out of those eligible to participate (denominator)
Measured: Collected antenatally at 24-28 weeks pregnancy
Number of women completed the secondary outcomes
The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)
Measured: Collected antenatally at 36 weeks pregnancy
Number of women completed the secondary outcomes
The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)
Measured: Collected antenatally at 3 months after delivery
Number of women completed the secondary outcomes
The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)
Measured: Collected antenatally at 6 months after delivery
Number of women completed the secondary outcomes
The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)
Measured: Collected antenatally at 9 months after delivery
Number of women completed the secondary outcomes
The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)
Measured: Collected antenatally at 12 months after delivery
Number of women randomised
The number of women randomised per month overall, and per month per study site.
Measured: Collected antenatally at 30 weeks pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start24 Jan 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Ministry of Education, Malaysia, Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Boon-How Chew, Universiti Putra Malaysia
- Investigators
- BOON HOW CHEW, Principal investigator, Universiti Putra MalaysiaKHALIDA ISMAIL, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204706
- Sponsor's protocol ID
- NMRR-21-1667-60212
- Acronym
- MyGODDESS
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 34446477Benton 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.
PubMed 36074545
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Trial of a Mobile Phone Application for the Primary Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT05204706
- Acronym / sponsor ID
- MyGODDESS / NMRR-21-1667-60212
- Conditions
- Gestational Diabetes, GDM, Pregnancy-Induced Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- King's College London, Ministry of Education, Malaysia, Ministry of Health, Malaysia
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Other: MyManis appWomen 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyManis appThe 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. | Other | Intervention arm |
Primary outcome
Number of women who were randomised to the treatment groups.
Time frame: Collected antenatally at 30 weeks pregnancy
The proportion of women who were randomised (numerator) out of those identified from the clinical registers (study population as denominator)
Number of women that take up the intervention
Time frame: Collected antenatally at 36 weeks pregnancy
The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)
Number of women that take up the intervention
Time frame: Collected antenatally at 6 months after delivery.
The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)
Number of women that take up the intervention
Time frame: Collected antenatally at 12 months after delivery.
The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)
Number of women withdrawn or loss to follow up
Time frame: Collected antenatally at 36 weeks pregnancy
The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)
Number of women withdrawn or loss to follow up
Time frame: Collected antenatally at 3 months after delivery
The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)
Number of women withdrawn or loss to follow up
Time frame: Collected antenatally at 6 months after delivery
The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)
Number of women withdrawn or loss to follow up
Time frame: Collected antenatally at 9 months after delivery
The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)
Number of women withdrawn or loss to follow up
Time frame: Collected antenatally at 12 months after delivery
The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)
8 secondary outcomes
Number of women consented
Time frame: Collected antenatally at 24-28 weeks pregnancy
Number of women randomised
Time frame: Collected antenatally at 24-28 weeks pregnancy
Number of women completed the secondary outcomes
Time frame: Collected antenatally at 36 weeks pregnancy
Number of women completed the secondary outcomes
Time frame: Collected antenatally at 3 months after delivery
Number of women completed the secondary outcomes
Time frame: Collected antenatally at 6 months after delivery
Number of women completed the secondary outcomes
Time frame: Collected antenatally at 9 months after delivery
Number of women completed the secondary outcomes
Time frame: Collected antenatally at 12 months after delivery
Number of women randomised
Time frame: Collected antenatally at 30 weeks pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- BackgroundMohd 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: PubMed 34446477Sobri 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.
- Background: PubMed 36074545Benton 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.
- UKRI website about the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IKLIL IMAN MOHD SA'ID contact
BOON HOW CHEW principal investigator
Universiti Putra Malaysia
KHALIDA ISMAIL principal investigator
King's College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyManis app in people with Gestational Diabetes and GDM, run by Universiti Putra Malaysia at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BOON HOW CHEW (0126900652, chewboonhow@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women who were randomised to the treatment groups. (time frame: Collected antenatally at 30 weeks pregnancy). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204706, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.