Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial (P3OPPY)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Pregnancy Complications; Maternal Distress; Adverse Birth Outcomes; Infant Conditions

Treatments: Behavioral: Community Health Worker; Behavioral: Digital Health Intervention plus Community Health Worker; Behavioral: Digital Health intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06510075

300013085

22HERNPMI985239 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: No Healthy Volunteers

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 major structural chromosomal abnormalities prior to enrollment
• Participated in POPPY Pilot

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Digital Health Intervention (DHI)

Experimental group

Description:

This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.

Treatment:

Behavioral: Digital Health intervention

Community health worker (CHW)

Experimental group

Description:

Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board

Treatment:

Behavioral: Community Health Worker

DHI Plus CHW

Experimental group

Description:

This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.

Treatment:

Behavioral: Digital Health Intervention plus Community Health Worker

Usual Care

No Intervention group

Description:

This group will receive routine prenatal care services.