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

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"

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).

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus; Continuous Glucose Monitoring
• Intervention / Treatment: Other: Blood glucose meters (BGM); Device: Continuous glucose monitor; Behavioral: Perinatal nursing care for gestational diabetes

Detailed Description

Background: Women with gestational diabetes mellitus (GDM) are more likely to develop cardiometabolic risk (CMR). CMR refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. However, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of GDM from developing CMR has rarely been studied.

Methods: This randomized controlled trial will recruit 120 GDM pregnant women in northern Taiwan. The participants will be randomly assigned to the control group (blood glucose meters (BGM); n=40 people), intervention group 1 (continuous glucose monitoring (CGM); n=40 people), intervention group 2 (HBM-based lifestyle and mHealth intervention + CGM; n=40 people).The comparison group will receive the routine care and finger-prick test for blood glucose monitoring (BGM) during pregnancy.The intervention group 1 will receive CGM during pregnancy. The intervention group 2 will receive a HBM-based lifestyle and mHealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including CGM during pregnancy.We intend to compare outcome variables among three groups. The outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. Outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. Generalized estimating equation (GEE) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUNG-HUI CHEN, PhD; Phone Number: 886-2-2394-7109; Email: hunghuichen@ntu.edu.tw

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 302058
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
    • Contact: HUNG-HUI CHEN; Phone Number: +886-2-23947109; Email: hunghuichen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or above
2. Pregnant women diagnosed with gestational diabetes mellitus
3. Willing to participate in the study

Exclusion Criteria:

1. Diagnosed with diabetes mellitus before pregnancy
2. Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
3. Abnormal coagulation function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Controlled group-Blood glucose meters (BGM) group; The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. 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.	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.
Experimental: Experimental group1-Continuous glucose monitoring (CGM) group; The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)". 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.	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.; Other Names: Abbott FreeStyle Libre 2 (CGM)
Experimental: Experimental group2-Continuous glucose monitoring (CGM) with nursing care group; The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)". 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. Participants will receive nursing care for gestational diabetes at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum.	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.; Other Names: Abbott FreeStyle Libre 2 (CGM); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results	This outcome measure assesses the number of participants with abnormal results from the Oral Glucose Tolerance Test (OGTT), which includes measurements of fasting, 1-hour, and 2-hour glucose levels. The data will be summarized based on the thresholds established for abnormal glucose levels, as per standard diagnostic criteria for gestational diabetes.	24-32 weeks of pregnancy, 4-12 weeks postpartum
HOMA-IR Value for Assessing Insulin Resistance in Participants	This outcome measure evaluates the HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) value in participants, calculated using fasting insulin and fasting glucose levels. Data will be obtained through reviews of medical records.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Total Cholesterol Levels in Participants	This outcome measure assesses the total cholesterol levels in participants. Data will be obtained through reviews of medical records. The data will be summarized by reporting the mean total cholesterol level, as well as the proportion of participants classified as having high total cholesterol levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Triglycerides Levels in Participants	This outcome measure assesses the triglycerides levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean triglycerides level, as well as the proportion of participants classified as having high triglycerides levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
High-density Lipoprotein Levels in Participants	This outcome measure assesses the high-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean high-density lipoprotein level, as well as the proportion of participants classified as having high high-density lipoprotein levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Low-density Lipoprotein Levels in Participants	This outcome measure assesses the low-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean low-density lipoprotein level, as well as the proportion of participants classified as having high low-density lipoprotein levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Glycated Albumin Levels in Participants	This outcome measure assesses the glycated albumin levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean glycated albumin level, as well as the proportion of participants classified as having high glycated albumin levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Fasting Plasma Glucose Levels in Participants	This outcome measure assesses the fasting plasma glucose levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean fasting plasma glucose level, as well as the proportion of participants classified as having high fasting plasma glucose levels based on established clinical thresholds.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Incidence of Fetal Macrosomia as Measured by Birth Weight	This outcome measure assesses the incidence of fetal macrosomia in participants. Data will be summarized by reporting the proportion of newborns classified as having fetal macrosomia based on the established weight threshold.	4-12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose monitoring satisfaction Scale	Satisfaction of using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale. A 4-item Likert scale includes 4 categories: ease of use, painful, convenience and overall satisfaction. Each item scores from 1-5. A higher score means lower satisfaction.	33 weeks of pregnancy to before delivery
Incidence of Hypertensive Disorders in Pregnancy	This outcome measure assesses the incidence of hypertensive disorders in pregnancy, including gestational hypertension, preeclampsia, and eclampsia. Data will be summarized by reporting the proportion of participants diagnosed with any hypertensive disorder during pregnancy.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Rate of Cesarean Section Deliveries	This outcome measure assesses the rate of cesarean section deliveries among participants.	4-12 weeks postpartum
Health Belief Scale for Glycemic Control	A 21-item Likert scale based on the Health Belief model includes 5 categories: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Perceived benefits and barriers of CGM assessed by Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires	The Benefits of Continuous Glucose Monitoring (BenCGM) and Burdens of Continuous Glucose Monitoring (BurCGM) Questionnaires will be used to assess participants' perceived benefits and barriers of using CGM. The data will be summarized as quantitative scores, with higher scores indicating greater perceived benefits or barriers, respectively. Each questionnaire includes multiple items rated on a Likert scale, and the total scores will be aggregated for each participant.	33 weeks of pregnancy to before delivery
Gestational Weight Gain as Measured by Weight Change Across Pregnancy Weeks or Total Weight Gain During Pregnancy	This outcome measure assesses gestational weight gain in participants, defined as the weight change between different pregnancy weeks or the total weight gain during pregnancy.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Depression Severity as Measured by the Edinburgh Postnatal Depression Scale (EPDS)	This outcome measure assesses the severity of depression in participants using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item questionnaire. Each item is scored from 0 to 3, resulting in a total score range from 0 to 30. Higher scores indicate a higher likelihood of depression, with scores above 12 or 13 suggesting probable depression.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Infant Growth Curve as Measured by WHO Growth Standards	This outcome measure assesses infant growth curves using the World Health Organization (WHO) growth standards. Data on infant weight, length, and head circumference will be collected at multiple time points. The data will be summarized by reporting the mean values at each time point and the proportion of infants classified as underweight, normal weight, or overweight.	4-12 weeks postpartum
Average Postpartum Weight Retention	The postpartum weight retention will be measured as the difference between pre-pregnancy weight and weight at 4-12 weeks postpartum	24-32 weeks of pregnancy, 4-12 weeks postpartum
Percentage of Participants on Insulin Medications	This outcome will report the proportion of participants who required insulin medications, expressed as a percentage of the total study population. Insulin use will be tracked through medical records and self-reports.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Average Exercise Frequency	Exercise frequency will be measured based on self-reported exercise sessions per week. The data will be summarized as an average number of sessions per week for the study population at each time point.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Health behavior change of glycemic control Scale	A 3-item Likert scale based on the Transtheoretical model, including self-monitoring of glucose level, diet and physical activity. Each item scores from 0-4. A higher score means closer to the action or maintenance stage.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Assessment of Quality of Life Using the World Health Organization Quality of Life Scale (WHOQOL-BREF) Taiwan Version	This measure assesses quality of life using the WHOQOL-BREF Taiwan version. Data will be aggregated and reported as domain-specific scores and an overall quality of life score, based on participant responses.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: HUNG-HUI CHEN, PhD, National Taiwan University Hostiptal

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Gestational Diabetes Mellitus; Health Interventions
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 202403080RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes