Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a nested randomized pilot trial within the TOFFFY cohort at KK Women's and Children's Hospital. It uses continuous glucose monitoring, wrist actigraphy, and a diet-logging app to characterize how chronobiology and meal timing relate to glucose dynamics in early pregnancy. The study aims to see if early behavioral and CGM-derived measures can predict later glucose regulation and metabolic outcomes, and whether real-time self-monitoring improves glycemic outcomes versus usual care. Eligible participants are pregnant women ≤13 weeks gestation enrolled in TOFFFY, excluding those with pre-existing diabetes or conditions affecting glucose metabolism. The intervention explores whether wearable and digital tools can identify at-risk individuals early and guide interventions to prevent GDM.

Why it matters

Who can join: the full rules

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

Where it's running

• KK Women's and Children's Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: See Ling Loy — KK Women's and Children's Hospital
• Study coordinator: Benjarat Oh
• Email: benjarat.oh@kkh.com.sg
• Phone: +6563948105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.