Clinical Trial

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

Study acronym: HAPPY
Active, Not Recruiting
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-09; most recent amendment 2025-05-13.
Status change: Recruiting → Active, Not Recruiting 2025-05-13
Status change: Not Yet Recruiting → Recruiting 2023-11-07
Trial Details
NCT Number NCT05949957
Lead Sponsor Institute for Human Development and Potential (IHDP), Singapore
Conditions Type 2 Diabetes, Healthy Lifestyle Behaviors, Gestational Diabetes
Enrollment 400 participants
Start Date 2023-10-20
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-05-16