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"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or above
- •Pregnant women diagnosed with gestational diabetes mellitus
- •Willing to participate in the study
排除标准
- •Diagnosed with diabetes mellitus before pregnancy
- •Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
- •Abnormal coagulation function
结局指标
主要结局
Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results
时间窗: 24-32 weeks of pregnancy, 4-12 weeks postpartum
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.
HOMA-IR Value for Assessing Insulin Resistance in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Total Cholesterol Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Triglycerides Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
High-density Lipoprotein Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Low-density Lipoprotein Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Glycated Albumin Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Fasting Plasma Glucose Levels in Participants
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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.
Incidence of Fetal Macrosomia as Measured by Birth Weight
时间窗: 4-12 weeks postpartum
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.
次要结局
- Rate of Cesarean Section Deliveries(4-12 weeks postpartum)
- Incidence of Hypertensive Disorders in Pregnancy(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery)
- Health Belief Scale for Glycemic Control(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery)
- Glucose monitoring satisfaction Scale(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(33 weeks of pregnancy to before delivery)
- Gestational Weight Gain as Measured by Weight Change Across Pregnancy Weeks or 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)(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(4-12 weeks postpartum)
- Average Postpartum Weight Retention(24-32 weeks of pregnancy, 4-12 weeks postpartum)
- Percentage of Participants on Insulin Medications(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum)
- Average Exercise Frequency(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum)
- Health behavior change of glycemic control Scale(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(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum)