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

NCT06510075 | Recruiting DMC

• 2 other identifiers: 30001308522HERNPMI985239
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pregnancy outcomes; Health inequities

Outcome Measures

Primary Outcomes (1)

• Weighted Adverse Outcome Score (WAOS)

  WAOS, calculated by adding the weights of all adverse events divided by the total number of deliveries. Maternal death=750, Neonatal death=400, Uterine rupture=100, Maternal ICU Admission=65, Birth trauma=60, Unanticipated operative procedure=40, NICU Admission=35, 5-minute Apgar \<7=25, Maternal blood transfusion=20, and 4th degree perineal lacerations=5.

  [Time Frame: From randomization to 6 weeks postpartum]

Secondary Outcomes (8)

• Outpatient Prenatal Care Visits

  Duration of pregnancy through 6 weeks postpartum

• Preterm Birth

  At birth

• Neonatal birthweight

  At birth

• Cesarean delivery

  At birth

• Maternal blood transfusion

  Duration of pregnancy through 6 weeks postpartum

Study Arms (4)

Digital Health Intervention (DHI)

EXPERIMENTAL

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.

Behavioral: Digital Health intervention

Community health worker (CHW)

EXPERIMENTAL

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

Behavioral: Community Health Worker

DHI Plus CHW

EXPERIMENTAL

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

Behavioral: Digital Health Intervention plus Community Health Worker

Usual Care

NO INTERVENTION

This group will receive routine prenatal care services.

Interventions

Digital Health intervention BEHAVIORAL

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

Also known as: DHI

Digital Health Intervention (DHI)

Community Health Worker BEHAVIORAL

Health care information delivered via CHW.

Also known as: CHW

Community health worker (CHW)

Digital Health Intervention plus Community Health Worker BEHAVIORAL

Health care information delivered via DHI plus CHW

Also known as: DHI plus CHW

DHI Plus CHW

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Heart Association: collaborator
• ConnectionHealth: collaborator
• Memora Health: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Rachel Sinkey, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Wally Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosylen "Roz" Quinney

CONTACT

205.934.1309; rquinney@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Study is a randomized trial (n=400) randomizing eligible participants to usual care (n=100), or usual care plus a digital health intervention (n=100), or usual care plus a community health worker intervention (n=100), or usual care plus both a digital health intervention and a community health worker intervention (n=100).

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)