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Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY
Sponsor: KK Women's and Children's Hospital
Summary
The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. The main questions it aims to answer are: 1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care? This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care). Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.
Official title: Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY
Key Details
Gender
FEMALE
Age Range
21 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-05-01
Completion Date
2027-06-30
Last Updated
2026-04-16
Healthy Volunteers
Yes
Conditions
Interventions
Continuous glucose monitor (CGM)
Participants will wear a continuous glucose monitor for 14 days in early pregnancy.
Wrist actigraphy device
A wrist actigraphy device will be used to assess sleep-wake patterns and physical activity over 14 days.
AI-based dietary and meal timing logging mobile application
Participants will record their dietary intake, meal timing logging, and feedback-based self-monitoring using an AI-based food logging mobile application.
Locations (1)
KK Women's and Children's Hospital
Singapore, Singapore, Singapore