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Clinical Trials in Singapore / NCT05949957
Active, not recruiting Not applicable

Harnessing Human Potential and Improving Health Span in Women and Their Children

NCT05949957 · tracked via the Priya Life Science Singapore tracker
Phase
Not applicable
Started
2023-10-20
Last updated
2026-09-15

Condition(s) studied

Type 2 DiabetesHealthy Lifestyle BehaviorsGestational Diabetes

Investigational drug(s) / intervention(s)

LvL UP AppHAPPY AppOura Ring And Oura App

LvL UP App: LvL UP App: A Smartphone-based conversational agent-delivered holistic lifestyle intervention. The intervention group will receive several digital coaching sessions focus on 3 pillars: diet, physical activity, and mental well-being to promote health literacy and promote healthy lifestyles. The app includes practical exercises per pillar (e.g., journaling, slow-breathing exercises, lifehacks).

HAPPY App: HAPPY App: Each subject will use the HAPPY App that aims to:(1) deliver health promotion information (guided by Singapore Health Promotion Board's resources), and (2) display health data collected (e.g., body mass index, blood pressure, OGTT results) that help them monitor own health and prevent T2D.

Oura Ring And Oura App: Oura ring and Oura App: Each subject will receive an Oura ring, i.e., an activity-tracking wearable that collects lifestyle data (physical activity, sleep and heart rate (as a proxy for stress) that will be synced with Oura App

Study 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

Sex
FEMALE
Min age
21 Years
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Singapore Institute for Clinical Sciences (SICS) Singapore Singapore

More Institute for Human Development and Potential (IHDP), Singapore trials in Singapore

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05949957 on ClinicalTrials.gov ↗ ← All trials in Singapore