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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:
Aims:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Arm | No Intervention | Subjects in the standard care arm will be informed of their increased risk of developing type 2 diabetes in the future, and given general lifestyle verbal advice to maintain a healthy weight, eat a well-balanced diet and do regular exercise during their 6 week postnatal visit. Women found to have impaired fasting glucose (6.1-6.9 mmol/L) or impaired glucose tolerance (2H post glucose of 7.8-11.0 mmol/L) will be issued a letter reinforcing lifestyle changes namely weight loss (if raised BMI), diet, exercise, and encouragement to consult a family physician to discuss the appropriateness of starting medications that can prevent the progression to type 2 diabetes, or restore the blood glucose to normal levels. Those with a normal OGTT result will just be informed that it is normal. | |
| Interactive Smartphone App Arm | Active Comparator | Participants will download the INTERACTIVE SMARTPHONE APP and will be briefed on its use by our team of nutritionists/dieticians, exercise physiologists and life style coaches. Weight: Participants will be reminded that the goal is satisfactory weight loss. NUH occupational therapist-trained lifestyle coaches, exercise physiotherapists, and clinical nutritionist/ dietician will interact with participants through real-time chats channels via the APP; all culturally appropriate and customized to the Singapore context. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Smartphone App | Device | There are six main components to the APP.
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight at 4 months post-delivery | Satisfactory weight is defined as return to weight at first booking visit (during 1st trimester) if booking BMI ≤23. If the booking weight is high (BMI>23), the goal would be return to weight that is 5% lower than booking weight. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Markers predictive of future type 2 diabetes and cardiometabolic risk | 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; and inflammatory risk: hsCRP, IL-6 | 4 months |
| Dietary assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eu Leong Yong | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724204 | Derived | Lim K, Chan SY, Lim SL, Tai BC, Tsai C, Wong SR, Ang SM, Yew TW, Tai ES, Yong EL. A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Mar 16;9(3):e22147. doi: 10.2196/22147. | |
| 31615456 | Derived | Lim K, Chi C, Chan SY, Lim SL, Ang SM, Yoong JS, Tsai C, Wong SR, Yew TW, Tai ES, Yong EL. Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes. BMC Public Health. 2019 Oct 15;19(1):1287. doi: 10.1186/s12889-019-7691-3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2017 | Jul 23, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D015431 | Weight Loss |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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A prospective Randomized Control Trial will be conducted to compare an INTERACTIVE SMARTPHONE APP versus STANDARD care to optimize post-delivery weight in women with recent GDM. The aim is to reduce diabetes and cardiometabolic risk.
During the antenatal period, subjects will be informed about the study during regular NUH nurse-led dietary counseling sessions. After delivery, women will be offered the opportunity to join the study. Informed consent will be obtained before discharge from hospital post-delivery. An appointment will be given for the first study visit at 6 weeks post-delivery.
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The subjects who participate in the study may be seeing the doctors or allied health professionals involved in this study at the clinic. However, recruitment will not be done by them though they will help to improve the awareness of such a study to their patients. There will be no coercion involved as the subjects have the full autonomy to decide if they wish to participate.
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|
Food Diary over 3 days to monitor the calorie intake and eating habits of the subject. |
| 4 months |
| Subject's Self Efficacy to Regulate Exercise | The scale is devised by Bandura, and participants have to rate their degree of confidence in performing the described situations with a number from 0 to 100. The higher the value, the greater confidence the subject has in doing the activity. | 4 months |
| Subject's Self Efficacy to Regulate Eating Habits | The scale is devised by Bandura, and participants have to rate their degree of confidence in performing the described situations with a number from 0 to 100. The higher the value, the greater confidence the subject has in doing the activity. | 4 months |
| Subject's response to the research study using the Health Education Impact Questionnaire | A comparison between subjects' responses in the control and intervention arm, through a series of questions with 4 options - strongly disagree, disagree, agree, or strongly agree. | 4 months |
| Subject's medical outcomes assessed through RAND-12 Item Health Survey | A comparison between subjects' responses in the control and intervention arm, through a series of questions about how she feels regarding aspects of her health and life. Questions are all multiple choice questions. | 4 months |
| Subjects' health expenditure | A comparison between subjects' expenditure in the control and intervention arm, to find out the cost effectiveness of the study. Bill sizes and monetary expenditure (in dollars) will be calculated for every individual to find the amount she has spent on healthcare postnatally, due to GDM in her pregnancy. | 4 months |
| DNA | DNA will be extracted and stored for future gene association studies with respect to type 2 diabetes susceptibility loci. | 4 months |
| Breastfeeding Status | Patients will be categorised into fully, partial or no breastfeeding | 4 months |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |