Clinical trial NCT06648174: The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus
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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Continuous Glucose Monitoring
Keywords: Gestational Diabetes Mellitus
Continuous Glucose Monitoring
Health Interventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results
timeFrame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
measure: HOMA-IR Value for Assessing Insulin Resistance in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Total Cholesterol Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Triglycerides Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: High-density Lipoprotein Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Low-density Lipoprotein Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Glycated Albumin Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Fasting Plasma Glucose Levels in Participants
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Incidence of Fetal Macrosomia as Measured by Birth Weight
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Incidence of Hypertensive Disorders in Pregnancy
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
measure: Rate of Cesarean Section Deliveries
timeFrame: 4-12 weeks postpartum
measure: Health Belief Scale for Glycemic Control
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
measure: Glucose monitoring satisfaction Scale
timeFrame: 33 weeks of pregnancy to before delivery
measure: Perceived benefits and barriers of CGM assessed by Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires
timeFrame: 33 weeks of pregnancy to before delivery
measure: Gestational Weight Gain as Measured by Weight Change Across Pregnancy Weeks or Total Weight Gain During Pregnancy
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
measure: Depression Severity as Measured by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Infant Growth Curve as Measured by WHO Growth Standards
timeFrame: 4-12 weeks postpartum
measure: Average Postpartum Weight Retention
timeFrame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
measure: Percentage of Participants on Insulin Medications
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Average Exercise Frequency
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Health behavior change of glycemic control Scale
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
measure: Assessment of Quality of Life Using the World Health Organization Quality of Life Scale (WHOQOL-BREF) Taiwan Version
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Study officials:
affiliation: National Taiwan University Hostiptal
name: HUNG-HUI CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: