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"

Overview

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.

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 an
• 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.

Primary outcome measures

• Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results [Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum]
• HOMA-IR Value for Assessing Insulin Resistance in Participants [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum]
• Total Cholesterol Levels in Participants [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum]
• Triglycerides Levels in Participants [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 [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 [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum]
• Glycated Albumin Levels in Participants [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 [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 [Time frame: 4-12 weeks postpartum]

Secondary outcome measures (12)

• Incidence of Hypertensive Disorders in Pregnancy [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery]
• Rate of Cesarean Section Deliveries [Time frame: 4-12 weeks postpartum]
• Health Belief Scale for Glycemic Control [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery]
• Glucose monitoring satisfaction Scale [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 [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 [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) [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 [Time frame: 4-12 weeks postpartum]
• Average Postpartum Weight Retention [Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum]
• Percentage of Participants on Insulin Medications [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum]
• Average Exercise Frequency [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 [Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum]

Eligibility criteria

Inclusion criteria

• Aged 18 years or above
• Pregnant women diagnosed with gestational diabetes mellitus
• Willing to participate in the study

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital — Hsinchu

Identifiers

NCT: NCT06648174 · 202403080RIND

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗