Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes
Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes
Gestational diabetes (GDM) complicates about 20% of pregnancies in Singapore. These women are
 at high risk of developing type 2 diabetes years after pregnancy; seven times more likely
 than normal. Achieving a healthy weight post-delivery is key to reduce the risk of future
 diabetes. This study, from a multidisciplinary team, intends to create a unique seamless care
 model to restore optimal weight post-delivery in women with recent GDM. The innovation
 examined in this randomized control trial is an INTERACTIVE SMARTPHONE APP. The APP monitors
 weight, dietary habits, and exercise activity patterns, gives feedback, and provides
 practical personalized lifestyle coaching that is culturally appropriate and customized to
 the Singapore context. If efficacy is confirmed in this RCT, the APP can be easily scaled up
 as a cost-effective way to potentially prevent or delay the onset of type 2 diabetes in
 Singaporean women. Additionally, measurement of markers of cardiometabolic risk will give
 indications on future cardiovascular health, utilizing an underused opportunity to improve
 women's health.
About 20% of pregnant Singaporean women are diagnosed with gestational diabetes (GDM),
 defined as the onset of glucose intolerance that is first recognized in pregnancy. These
 women are at seven times higher risk of developing type 2 diabetes in the future. About 20 -
 50% of women who were diagnosed with GDM during their pregnancies eventually develop type 2
 diabetes, with resultant huge health care costs for Singapore and other countries globally.
 The Diabetes Prevention Program Study has shown that lifestyle changes resulting in modest
 weight loss are effective in preventing type 2 diabetes in women with a history of GDM. The
 investigators estimate that about 50% of all type 2 diabetes in women in Singapore occurs
 when they have a history of GDM and represent a sizeable subpopulation where primary
 prevention could have a highly significant national impact. Preliminary data indicates that
 after birth, women with GDM are overwhelmed with care for the newborn and tend to neglect
 their own health needs. They welcome reminders and coaching but are time-challenged and
 cannot attend regular on-site lifestyle coaching sessions.

 Hypothesis:

 1. Use of an INTERACTIVE SMARTPHONE APP that can track weight, diet and activity linked to
 an interactive lifestyle coaching intervention can restore optimal weight in women with
 recent GDM. The team hypothesizes that at 4 months post-delivery, participants in the
 intervention arm will have significantly higher probability of returning to weight at
 the start of pregnancy, a significantly improved cardiometabolic status and overall
 lower risk profile for type 2 diabetes development compared with those receiving
 standard care (control).

 2. The use of this INTERACTIVE SMARTPHONE APP is cost-effective from the perspective of the
 Singapore healthcare system.

 Aims:

 1. To conduct a randomized control trial to examine the efficacy of an INTERACTIVE
 SMARTPHONE APP, customized for Singaporean women with recent GDM, in optimizing
 post-delivery weight and metabolic profiles compared with standard care.

 Primary outcome:

 -  Restoration of booking weight if previous booking BMI ≤ 23

 -  Weight loss of 5% with respect to booking weight if BMI > 23

 Secondary outcomes:

 - Improved cardiometabolic and inflammatory markers: fasting and 2h post-glucose load
 plasma glucose in an oral glucose tolerance test, HbA1C, advanced glycation
 end-products, C-peptide, HOMA-IR, lipid profile, liver function, hsCRP, IL-6.

 2. Evaluate the relative cost-effectiveness of this INTERACTIVE SMARTPHONE APP compared to
 standard care within the Singapore healthcare system in terms of improvements in quality
 of life, feasibility, acceptability, scalability and sustainability.
Inclusion Criteria:

 -  Female aged 21 years and above

 -  Plans to deliver in NUH

 -  Diagnosed with GDM antenatally (between 24-34 weeks gestation) defined using the 2013
 World Health Organization criteria (fasting plasma glucose = 5.1 mmol/L, plasma
 glucose at 1H <10 or plasma glucose at 2H post 75gm glucose load of =8.5 mmol/L)

 -  Has a smartphone and able to independently use a smartphone app

 -  Willing to provide a blood sample

 -  Able to give written informed consent

 -  Able to speak and read English

 Exclusion Criteria:

 -  Subjects with type 1 and/or type 2 diabetes (including suspected cases diagnosed by an
 abnormal oral glucose tolerance test in the 1st and early 2nd trimesters of pregnancy)

 -  drugs that affect glucose or lipid metabolism (e.g. systemic steroids, metformin,
 insulin, statins, orlistat)

 -  terminal or life threatening condition

 -  physical or mental condition that would prevent completion of a majority of study
 instruments.