Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

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.

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

Interventions

DEVICE

Continuous glucose monitor (CGM)

Participants will wear a continuous glucose monitor for 14 days in early pregnancy.

DEVICE

Wrist actigraphy device

A wrist actigraphy device will be used to assess sleep-wake patterns and physical activity over 14 days.

BEHAVIORAL

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.

Sponsors & Collaborators

• KK Women's and Children's Hospital

  lead OTHER_GOV

Principal Investigators

• See Ling Loy · KK Women's and Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-04-30

Completion

2027-06-30

Countries

• Singapore

Study Locations