Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05204706
Study type Interventional
Source Universiti Putra Malaysia
Contact BOON HOW CHEW
Phone 0126900652
Email chewboonhow@upm.edu.my
Status Recruiting
Phase N/A
Start date January 24, 2022
Completion date April 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Terminated NCT03749889 - Low Carb vs Normal Carb in Pregnancy N/A
Completed NCT03859193 - Education Nutritional Video for Gestational Diabetics N/A
Recruiting NCT05037526 - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes N/A
Completed NCT06178250 - Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester N/A
Not yet recruiting NCT06445530 - Nutrition Optimization and Community Upliftment for Postpartum Recovery N/A
Not yet recruiting NCT06310356 - Continuous Glucose Monitoring for Women With Gestational Diabetes N/A
Recruiting NCT02590016 - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial Phase 4
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01947699 - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide Phase 4
Recruiting NCT03008824 - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby N/A
Active, not recruiting NCT01340924 - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00371306 - Comparison of Glucovance to Insulin for Diabetes During Pregnancy N/A
Completed NCT03388723 - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting NCT04521712 - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Active, not recruiting NCT03301792 - Group Versus Traditional Prenatal Care for Diabetes N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition