Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510075
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Providing an Optimized and Empowered Pregnancy for You POPPY Aim 3 Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Providing an Optimized and emPowered Pregnancy for You PᵌOPPY Aim 3 Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
P3OPPY
Brief Summary:
The PᵌOPPY study is designed to support the American Heart Associations mission to improve maternalinfant health outcomes and address inequities in maternalinfant health care The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network HERN is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information care and experiences during pregnancy postnatal and postpartumpreconception periods particularly for Black and under-served populations Collectively the investigators will collaborate with pregnant and postpartum individuals and their families hospitals and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes In this trial 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions digital health interventions and community health workers reduce adverse pregnancy outcomes
Detailed Description:
The aim of this trial is to assess whether an existing Digital Heath Intervention DHI andor a Community Health Worker CHW Intervention will reduce adverse maternal and perinatal outcomes A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black NHB patients living in high area deprivation index ADI communities will be conducted Participants n400 will be randomized 1111 to one of 4 arms 1 standard prenatal care PNC alone or 2 standard PNC plus DHI or 3 standard PNC plus CHW or 4 standard PNC plus DHI and CHW
The PᵌOPPY study is designed to support the American Heart Associations mission to improve maternalinfant health outcomes and address inequities in maternalinfant health care The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative sustainable and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond
The PᵌOPPY study is designed to support the American Heart Associations mission to improve maternalinfant health outcomes and address inequities in maternalinfant health care The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative sustainable and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond
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