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RECRUITING
NCT06648174
NA

The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

This study aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).

Official title: The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus: The Development and Application of "a Lifestyle Intervention Based on Health Belief Model Supported by Mobile Health"

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-11-11

Completion Date

2027-12-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DEVICE

Continuous glucose monitor

Participants will receive a set of continuous glucose monitor (CGM) at 24-32 weeks of pregnancy (first set); and 33 weeks of pregnancy to before delivery (second set) respectively. CGM wearing instruction will be provided before the first wearing at 24-32 weeks of pregnancy. After completing the first wearing (approximately 7-14 days after starting to wear), the investigators will provide glucose monitor reports. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor reports was given approximately 7-14 days after starting to wear.

BEHAVIORAL

Perinatal nursing care for gestational diabetes

Individual nursing care and consultation for women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum.

OTHER

Blood glucose meters (BGM)

Participants are required to use blood glucose meters (BGM) at 24-32 weeks of pregnancy and 33 weeks to before delivery. After 7-14 days of glucose monitoring at 24-32 weeks of pregnancy, glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at 33 weeks to before delivery, another glucose monitor reports will be given to the participants.

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, Taiwan