Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320054
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-05
Brief Title:
Preventing Obstetric Complications With Dietary Intervention
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Preventing Common Obstetric Complications Through an Immersive Medically Tailored Meal Program
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
PLATE
Brief Summary:
The goal of this study is to learn whether access to healthy and fresh food health coaching and nutrition support intervention can reduce adverse birth outcomes in pregnant women The main questions it aims to answer are
Does access to healthy and fresh food health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns
Are participants able to successfully utilize the health program Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study Participants will be randomly assigned to one of two groups
Participants in the standard of care will be asked to
Complete surveys
Biometric screenings
Participants in the intervention group will be asked to
Complete surveys
Biometric screenings
Participate in weekly personal health coaching
Receive and consume provided weekly meals
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including gestational weight gain blood pressure diagnosis of gestational diabetes diagnosis of gestational hypertension or preeclampsia and gestational age at birth
Does access to healthy and fresh food health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns
Are participants able to successfully utilize the health program Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study Participants will be randomly assigned to one of two groups
Participants in the standard of care will be asked to
Complete surveys
Biometric screenings
Participants in the intervention group will be asked to
Complete surveys
Biometric screenings
Participate in weekly personal health coaching
Receive and consume provided weekly meals
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including gestational weight gain blood pressure diagnosis of gestational diabetes diagnosis of gestational hypertension or preeclampsia and gestational age at birth
Detailed Description:
None
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