Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
University of Alabama at Birmingham
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.
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 Ame…
Eligibility
- Age range
- 16–49 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Declines randomization * Speaks or writes in languages other than English * Currently incarcerated * Fetal demise diagnosed prior to enrollment * Known m…
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
Location
- University of Alabama at BirminghamBirmingham, Alabama