Clinical trial NCT05204706: The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
GDM
Pregnancy-Induced Diabetes
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: King's College London
name: Ministry of Education, Malaysia
name: Ministry of Health, Malaysia
First posted: 2022-01-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of women who were randomised to the treatment groups.
timeFrame: Collected antenatally at 30 weeks pregnancy
measure: Number of women that take up the intervention
timeFrame: Collected antenatally at 36 weeks pregnancy
measure: Number of women that take up the intervention
timeFrame: Collected antenatally at 6 months after delivery.
measure: Number of women that take up the intervention
timeFrame: Collected antenatally at 12 months after delivery.
measure: Number of women withdrawn or loss to follow up
timeFrame: Collected antenatally at 36 weeks pregnancy
measure: Number of women withdrawn or loss to follow up
timeFrame: Collected antenatally at 3 months after delivery
measure: Number of women withdrawn or loss to follow up
timeFrame: Collected antenatally at 6 months after delivery
measure: Number of women withdrawn or loss to follow up
timeFrame: Collected antenatally at 9 months after delivery
measure: Number of women withdrawn or loss to follow up
timeFrame: Collected antenatally at 12 months after delivery
Secondary outcomes:
measure: Number of women consented
timeFrame: Collected antenatally at 24-28 weeks pregnancy
measure: Number of women randomised
timeFrame: Collected antenatally at 24-28 weeks pregnancy
measure: Number of women completed the secondary outcomes
timeFrame: Collected antenatally at 36 weeks pregnancy
measure: Number of women completed the secondary outcomes
timeFrame: Collected antenatally at 3 months after delivery
measure: Number of women completed the secondary outcomes
timeFrame: Collected antenatally at 6 months after delivery
measure: Number of women completed the secondary outcomes
timeFrame: Collected antenatally at 9 months after delivery
measure: Number of women completed the secondary outcomes
timeFrame: Collected antenatally at 12 months after delivery
measure: Number of women randomised
timeFrame: Collected antenatally at 30 weeks pregnancy
Other outcomes:
measure: Body weight at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Body weight at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Body weight at T2
timeFrame: Collected antenatally at T2: 3 months after delivery
measure: Body weight at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Body weight at T4
timeFrame: Collected antenatally at T4: 9 months after delivery
measure: Body weight at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Height at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Body mass index at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Body mass index at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Body mass index at T2
timeFrame: Collected antenatally at T2: 3 months after delivery
measure: Body mass index at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Body mass index at T4
timeFrame: Collected antenatally at T4: 9 months after delivery
measure: Body mass index at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Body fat percentage at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Body fat percentage at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Body fat percentage at T2
timeFrame: Collected antenatally at T2: 3 months after delivery
measure: Body fat percentage at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Body fat percentage at T4
timeFrame: Collected antenatally at T4: 9 months after delivery
measure: Body fat percentage at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Blood pressure reading at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Blood pressure reading at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Blood pressure reading at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Blood pressure reading at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Total Cholestrol at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Total Cholestrol at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Total Cholestrol at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Total Cholestrol at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Low Density Lipoprotein Cholestrol at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Low Density Lipoprotein Cholestrol at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Low Density Lipoprotein Cholestrol at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Low Density Lipoprotein Cholestrol at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: High Density Lipoprotein cholesterol at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: High Density Lipoprotein cholesterol at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: High Density Lipoprotein cholesterol at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: High Density Lipoprotein cholesterol at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: HbA1c at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: HbA1c at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: HbA1c at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: HbA1c at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Fasting blood glucose at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Fasting blood glucose at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Oral glucose tolerance test (OGTT) Fasting at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Oral glucose tolerance test (OGTT) Fasting at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Oral glucose tolerance test (OGTT) 2-hour Postprandial at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Oral glucose tolerance test (OGTT) 2-hour Postprandial at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Fasting Serum Insulin at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Fasting Serum Insulin at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Fasting Serum Insulin at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Fasting Serum Insulin at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Insulin resistance at T0
timeFrame: Collected antenatally at T0: 30 weeks pregnancy
measure: Insulin resistance at T1
timeFrame: Collected antenatally at T1: 36 weeks pregnancy
measure: Insulin resistance at T3
timeFrame: Collected antenatally at T3: 6 months after delivery
measure: Insulin resistance at T5
timeFrame: Collected antenatally at T5: 12 months after delivery
measure: Total score for Self-efficacy for exercise at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Total score for Self-efficacy for exercise at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Total score for Self-efficacy for exercise at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Mother-infant relationship at T0
timeFrame: Collected at 30 weeks pregnancy
measure: Mother-infant relationship at T3
timeFrame: Collected at 6 months after delivery
measure: Mother-infant relationship at T5
timeFrame: Collected at 12 months after delivery
measure: Depressive symptoms at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Depressive symptoms at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Depressive symptoms at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Dietary intake at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Dietary intake at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Dietary intake at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Physical activity at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Physical activity at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Physical activity at T5
timeFrame: Collected at T5: 12 months after delivery
measure: mean step count at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: mean step count at T3
timeFrame: Collected at T3: 6 months after delivery
measure: mean step count at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Infant feeding T3
timeFrame: Collected at T3: 6 months after delivery
measure: Infant feeding at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Alcohol intake at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Alcohol intake at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Alcohol intake at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Smoking status at T0
timeFrame: Collected at T0: 30 weeks pregnancy
measure: Smoking status at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Smoking status at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Recruitment rate
timeFrame: Collected at 30 weeks pregnancy
measure: T1 Dosage delivered - app download
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T3 Dosage delivered - app download
timeFrame: Collected at T3: 6 months after delivery
measure: T5 Dosage delivered - app download
timeFrame: Collected at T5: 12 months after delivery
measure: T1 Dosage delivered - Support group
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T3 Dosage delivered - Support group
timeFrame: Collected at T3: 6 months after delivery
measure: T5 Dosage delivered - Support group
timeFrame: Collected at T5: 12 months after delivery
measure: T1 Dosage received - Participant's engagement
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T3 Dosage received - Participant's engagement
timeFrame: Collected at T3: 6 months after delivery
measure: T5 Dosage received - Participant's engagement
timeFrame: Collected at T5: 12 months after delivery
measure: T1 Dosage received - length of log in
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T3 Dosage received - length of log in
timeFrame: Collected at T3: 6 months after delivery
measure: T5 Dosage received - length of log in
timeFrame: Collected at T5: 12 months after delivery
measure: T1 Dosage received - time spent on DIET component
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T1 Dosage received - time spent on EXERCISE component
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T1 Dosage received - time spent on MENTAL HEALTH component
timeFrame: Collected at T1: 36 weeks pregnancy
measure: T3 Dosage received - time spent on DIET component
timeFrame: Collected at T3: 6months after delivery
measure: T3 Dosage received - time spent on EXERCISE component
timeFrame: Collected at T3: 6months after delivery
measure: T3 Dosage received - time spent on MENTAL HEALTH component
timeFrame: Collected at T3: 6months after delivery
measure: T5 Dosage received - time spent on DIET component
timeFrame: Collected at T5: 12 months after delivery
measure: T5 Dosage received - time spent on EXERCISE component
timeFrame: Collected at T5: 12 months after delivery
measure: T5 Dosage received - time spent on MENTAL HEALTH component
timeFrame: Collected at T5: 12 months after delivery
measure: Fidelity at T1
timeFrame: collected at T1: 36 weeks pregnancy
measure: Fidelity at T3
timeFrame: collected at T3: 6 months after delivery
measure: Fidelity at T5
timeFrame: collected at T5: 12 months after delivery
measure: Semi-structured interview at T1
timeFrame: Collected at T1: 36 weeks pregnancy
measure: Semi-structured interview at T3
timeFrame: Collected at T3: 6 months after delivery
measure: Semi-structured interview at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Mother infant relationship at T2
timeFrame: Collected at T2: 3 months after delivery
measure: Satisfaction survey at T5
timeFrame: Collected at T5: 12 months after delivery
measure: Hypertension
timeFrame: Collected at T2: 3 months postpartum
measure: Hypercholesterolemia
timeFrame: Collected at T2: 3 months postpartum
measure: Delivery method
timeFrame: Collected at T2: 3 months postpartum
measure: Pregnancy complications
timeFrame: Collected at T2: 3 months postpartum
measure: Birth complications
timeFrame: Collected at T2: 3 months postpartum
measure: Breastfeeding status on discharge
timeFrame: Collected at T2: 3 months postpartum
measure: Neonatal birth weight
timeFrame: Collected at T2: 3 months postpartum
measure: Neonatal APGAR score 5 minutes
timeFrame: Collected at T2: 3 months postpartum
measure: Congenital anomaly
timeFrame: Collected at T2: 3 months postpartum
measure: Congenital pnuemonia / heart defects
timeFrame: Collected at T2: 3 months postpartum
measure: Admission to neonatal intensive care
timeFrame: Collected at T2: 3 months postpartum
measure: Length of stay at the hospital ward
timeFrame: Collected at T2: 3 months postpartum
Locations:
city: Petaling Jaya
country: Malaysia
facility: Klinik Kesihatan Puchong Batu 14
state: Selangor
city: Seri Kembangan
country: Malaysia
facility: Klinik Kesihatan Seri Kembangan
state: Selangor
city: Putrajaya
country: Malaysia
facility: Klinik Kesihatan Putrajaya Presint 9
state: Wilayah Persekutuan
Study officials:
affiliation: Universiti Putra Malaysia
name: BOON HOW CHEW
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: KHALIDA ISMAIL
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.