NCT06510075

Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 16 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant 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 postpartum/preconception 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) and/or 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 (n=400) will be randomized 1:1:1:1 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 Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant 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.

Conditions

• Pregnancy Complications
• Maternal Distress
• Adverse Birth Outcomes
• Infant Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Digital Health intervention	Health care information delivered via a link in a text message that is then opened in a secure browser.
BEHAVIORAL	Community Health Worker	Health care information delivered via CHW.
BEHAVIORAL	Digital Health Intervention plus Community Health Worker	Health care information delivered via DHI plus CHW

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-31
• Completion: 2027-01-31
• First posted: 2024-07-19
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States