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).
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
Allocation
RANDOMIZED
Purpose
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.
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.
National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Hsinchu, Taiwan
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4-12 weeks postpartum
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.
Time frame: 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.
Time frame: 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.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum