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NCT05949957
Harnessing Human Potential and Improving Health Span in Women and Their Children
Conditions: Type 2 Diabetes, Healthy Lifestyle Behaviors, Gestational Diabetes
Sex: Female
Ages: 21 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 400
Sponsor: Institute for Human Development and Potential (IHDP), Singapore
Location: Singapore Institute for Clinical Sciences (SICS) Singapore
Summary
Women with Gestational Diabetes Mellitus (GDM) are 12-times more likely to develop Type 2 Diabetes (T2D) 4-6 years after delivery than women without GDM. There has been evidence that lifestyle modifications such as physical activity (PA), dietary intake, sleep, and stress management can prevent or delay type 2 diabetes (T2D). The purpose of this study is to assess the efficacy of a holistic lifestyle digital health intervention with post-GDM women in large community settings in Singapore. The study consists of a 1-year randomized controlled trial (RCT) with 3 years follow-up. Women who are eligible for the study will be randomized to either Group 1 (Intervention) or Group 2 (Control) at baseline. Both groups will be followed in years 2-4. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the "HAPPY app," which will provide health promotion information about physical activity, diet, sleep, and mental wellbeing, as well as display the information collected (such as body mass index, blood pressure, and OGTT results). The active group will receive the "LVL UP app" a smartphone-based chatbot-delivered intervention, designed to provide personalized recommendations through multiple digital coaching sessions aimed at improving health literacy and practicing healthy lifestyles to prevent Type 2 diabetes and common mental disorders (i.e., anxiety, depression).
Eligibility Criteria
Inclusion Criteria:
1. Female, age: 21 - 45 years
2. Had a history of GDM (at least 1 year and not more than 10 years)
3. Chinese, Malay or Indian ethnic groups
4. Body mass index (at least 18.5 kg/m2 and not more than 35 kg/m2)
5. Not planning to conceive in the next one year
6. Not performing exclusive breastfeeding during study period
7. Own a smartphone compatible with the study mobile Apps
8. Proficient in English language
9. Plan to stay in Singapore for the next 4 years
10. Willing to comply to study protocol
11. Able to provide a written informed consent
Exclusion Criteria:
1. Current or previous diagnosis of diabetes (Type 1 or 2), except GDM
2. Currently pregnant
3. Given birth within the last 12 weeks
4. Severely limited mobility (e.g., wheelchair bound, require long-term walking aid, etc.)
5. Diagnosed with malnutrition or eating disorder
6. Diagnosed with cancers, unstable heart diseases, severe kidney diseases, severe liver diseases
7. Diagnosed with severe insomnia, unstable mental conditions, dementia, or cognitive impairment
8. Experienced alcohol or drug abuse
9. Currently having medications known to influence glucose metabolism (e.g. peroral corticosteroids)
10. Currently participating in concurrent clinical trial or lifestyle intervention study
Source: ClinicalTrials.gov (NCT05949957). StuddyBuddy aggregates publicly available trial information.