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ACTIVE NOT RECRUITING
NCT05949957
NA

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

Sponsor: Institute for Human Development and Potential (IHDP), Singapore

View on ClinicalTrials.gov

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).

Official title: Harnessing Human Potential and Improving Health Span in Women and Their Children: a Randomized Controlled Trial and Follow-up (HAPPY STUDY)

Key Details

Gender

FEMALE

Age Range

21 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-10-20

Completion Date

2026-09

Last Updated

2025-05-16

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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).

BEHAVIORAL

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.

BEHAVIORAL

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

Locations (1)

Singapore Institute for Clinical Sciences (SICS)

Singapore, Singapore, Singapore