Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648174
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infants 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 n40 people intervention group 1 continuous glucose monitoring CGM n40 people intervention group 2 HBM-based lifestyle and mHealth intervention CGM n40 peopleThe comparison group will receive the routine care and finger-prick test for blood glucose monitoring BGM during pregnancyThe 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 pregnancyWe 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
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 n40 people intervention group 1 continuous glucose monitoring CGM n40 people intervention group 2 HBM-based lifestyle and mHealth intervention CGM n40 peopleThe comparison group will receive the routine care and finger-prick test for blood glucose monitoring BGM during pregnancyThe 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 pregnancyWe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None