Status:
UNKNOWN
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Jana Care
Conditions:
Gestational Diabetes
Pregnancy Complications
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can result in short and long term complications for mother and child. Mobile applications are effective in improvin...
Detailed Description
Gestational diabetes mellitus (GDM) is defined as glucose intolerance of any degree with onset or first recognition during pregnancy. In Singapore, 20-30% of pregnant women are affected by GDM. If poo...
Eligibility Criteria
Inclusion
- Ability to provide informed consent.
- Women aged 21 years and older.
- Singleton pregnancy.
- GDM diagnosed between 12 to 30 weeks of gestation, based on the 2013 World Health Organization (WHO) criteria, i.e. either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
- Possesses a smartphone and ability to navigate a smartphone app.
- Proficient in English language.
- Plan to deliver the baby in National University Hospital.
Exclusion
- Multiple pregnancy.
- Pre-existing diabetes (type 1 diabetes, type 2 diabetes, or other specific types of diabetes) diagnosed prior to current pregnancy.
- GDM diagnosed before 12 weeks of gestation.
- No weight available in first trimester (at or before 12 weeks gestation) of the pregnancy.
- Need for insulin therapy from the start of diagnosis of GDM, as determined by the primary clinician.
- Heart failure.
- Chronic kidney disease
- Feeding and eating disorders.
- History of bariatric surgery.
- Long-term systemic corticosteroids use.
- Impaired mobility.
- Concomitant participation in another clinical study (i.e. Phase I-III clinical studies) with investigational medicinal product(s).
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03249896
Start Date
September 5 2017
End Date
May 1 2019
Last Update
May 29 2019
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119228