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Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

Sponsor: KK Women's and Children's Hospital • ClinicalTrials.gov ID: NCT07534670

Registry updated: 2026-09-15

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Description

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.

Interventions

Continuous glucose monitor (CGM) (Device)
Participants will wear a continuous glucose monitor for 14 days in early pregnancy.
Wrist actigraphy device (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 (Behavioral)
Participants will record their dietary intake, meal timing logging, and feedback-based self-monitoring using an AI-based food logging mobile application.

Eligibility criteria

Inclusion Criteria: * Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235) * Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment Exclusion Criteria: * Females with pre-existing diabetes mellitus (Type 1 or Type 2) and/or chronic medical conditions affecting glucose metabolism * Females who are taking medications known to significantly affect glucose metabolism * Females with multiple pregnancy (e.g., twins or higher-order gestation) * Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device

Conditions

Continuous Glucose Monitoring Diabetes, Gestational Diet During Pregnancy Meal Time Actigraphy Pregnancy Glucose Intolerance During Pregnancy Gestational Diabetes Mellitus in Pregnancy Circadian Rhythm Sleep Chronobiology Wearable Electronic Devices Mobile Applications Blood Glucose Profile Metabolic Diseases Randomized Controlled Trial Pilot Study

Locations

KK Women's and Children's Hospital — Singapore, Singapore, Singapore

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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