RecruitingNot ApplicableNCT06510075

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


Sponsor

University of Alabama at Birmingham

Enrollment

400 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 49 Years

Inclusion Criteria9

  • Self Identifies as Non-Hispanic Black
  • Between 16-49 years old
  • Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
  • Live singleton or dichorionic twin gestation
  • Dating sonogram at \<23 weeks gestation,
  • Area Deprivation Index (ADI) National 4th or 5th Quintile
  • Planning to deliver at UAB Hospital
  • Speaks and writes in English
  • No indication for delivery at the time of enrollment

Exclusion Criteria6

  • Declines randomization
  • Speaks or writes in languages other than English
  • Currently incarcerated
  • Fetal demise diagnosed prior to enrollment
  • Known major structural chromosomal abnormalities prior to enrollment
  • Participated in POPPY Pilot

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALDigital Health intervention

Health care information delivered via a link in a text message that is then opened in a secure browser.

BEHAVIORALCommunity Health Worker

Health care information delivered via CHW.

BEHAVIORALDigital Health Intervention plus Community Health Worker

Health care information delivered via DHI plus CHW


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06510075


Related Trials