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Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

RecruitingNAAges 21 Years - 39 YearsFemaleKK Women's and Children's Hospital
NCT07534670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Towa

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📋 Eligibility rules (as published)
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
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What it tests

  • Continuous glucose monitor (CGM)
  • Wrist actigraphy device
  • AI-based dietary and meal timing logging mobile application
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Where

1 site
KK Women's and Children's Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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