An interventional study of Interactive Smartphone App in Gestational Diabetes, Weight Loss and Diet Habit, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Prevention
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:
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's enrollment of 200 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Device: Interactive Smartphone App
There are six main components to the APP. * Goal Setting: personalizes diet, activity, and weight loss goals for patients based on their starting point. * Food choices and recommendations: App has an automated and immediate recommendation of foods if the choice selected from food database is not optimal. It has a calorie and nutrients tracker to enable patients to track their food intake. * Activity and steps tracker: App has a pedometer to count physical activity and steps to enable patients to track their progress towards goals. * Interactive video lessons: App has video lessons pushed weekly to the patient according to her needs. The videos encompass aspects of diet, lifestyle and behavior management. * Healthcare Professionals Support: App has a chat channel to enable interaction between participants and healthcare professionals.
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.
Time frame: 4 months
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
Time frame: 4 months
Dietary assessment
Food Diary over 3 days to monitor the calorie intake and eating habits of the subject.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
DNA
DNA will be extracted and stored for future gene association studies with respect to type 2 diabetes susceptibility loci.
Time frame: 4 months
Breastfeeding Status
Patients will be categorised into fully, partial or no breastfeeding
Time frame: 4 months
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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