Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445270
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes GDM as compared to the current standard diet and activity counseling
Detailed Description:
GDM is associated with adverse maternal and newborn outcomes as well as potential lifelong consequences Currently clinical guidelines recommend screening for pre-existing Type 2 diabetes mellitus at new obstetric visits for individuals at high risk of developing GDM For those who do not screen positive but still may be at risk for GDM standard practice is for basic diet exercise and weight gain counseling
In this study eligible participants will be randomized into one of two groups usual care with standard diet and exercise counseling or a GDM prevention program that consists of a more intensive exercise and monitoring program
All participants will be asked to wear an activity tracker and continuous glucose monitors CGMs at specified time points throughout their pregnancy Blood will be drawn at specified time points to measure hemoglobin A1c lipids and HOMA-IR measures
In this study eligible participants will be randomized into one of two groups usual care with standard diet and exercise counseling or a GDM prevention program that consists of a more intensive exercise and monitoring program
All participants will be asked to wear an activity tracker and continuous glucose monitors CGMs at specified time points throughout their pregnancy Blood will be drawn at specified time points to measure hemoglobin A1c lipids and HOMA-IR measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None