NCT03324737

Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes

Primary Prevention of Type 2 Diabetes: A Randomized Control Trial With Interactive Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gestational Diabetes
• Weight Loss
• Diet Habit

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-16
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2017-10-30
• Last updated: 2019-08-08

Locations

1 site across 1 country: Singapore