NCT07534670 Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY
| NCT ID | NCT07534670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Continuous Glucose Monitoring |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
See Ling Loy
PRINCIPAL INVESTIGATOR
KK Women's and Children's Hospital
Frequently Asked Questions
Who can join the NCT07534670 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 39 Years, studying Continuous Glucose Monitoring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07534670 currently recruiting?
Yes, NCT07534670 is actively recruiting participants. Contact the research team at benjarat.oh@kkh.com.sg for enrollment information.
Where is the NCT07534670 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07534670 clinical trial?
NCT07534670 is sponsored by KK Women's and Children's Hospital. The principal investigator is See Ling Loy at KK Women's and Children's Hospital. The trial plans to enroll 140 participants.