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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-49
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Declines randomization

Speaks or writes in languages other than English

Currently incarcerated

Fetal demise diagnosed prior to enrollment

Trial design

Treatments tested in this trial

  • Digital Health intervention
  • Community Health Worker
  • Digital Health Intervention plus Community Health Worker

Treatment groups

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

American Heart Association

Collaborator

ConnectionHealth

Collaborator

Memora Health

Collaborator