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

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Infant Conditions; Maternal Distress; Adverse Birth Outcomes
• Intervention / Treatment: Behavioral: Digital Health intervention; Behavioral: Community Health Worker; Behavioral: Digital Health Intervention plus Community Health Worker

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosylen "Roz" Quinney; Phone Number: 205.934.1309; Email: rquinney@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Rosylen Quinney; Phone Number: 205.934.1309; Email: rquinney@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHI Plus CHW; 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; Health care information delivered via DHI plus CHW; Other Names: DHI plus CHW
No Intervention: Usual Care; This group will receive routine prenatal care services.
Experimental: Digital Health Intervention (DHI); 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; Health care information delivered via a link in a text message that is then opened in a secure browser.; Other Names: DHI
Experimental: Community health worker (CHW); 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; Health care information delivered via CHW.; Other Names: CHW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outpatient Prenatal Care Visits	Number of outpatient prenatal care and postpartum visits	Duration of pregnancy through 6 weeks postpartum
Preterm Birth	Delivery of a neonate at less than 37 weeks	At birth
Neonatal birthweight	Weight of neonate at birth	At birth
Cesarean delivery	Occurrence of a cesarean birth	At birth
Maternal blood transfusion	Transfusion of blood products	Duration of pregnancy through 6 weeks postpartum
Breastfeeding intent	Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization	From randomization to delivery of the infant(s)
Maternal postpartum readmission	Admission of the mother to the hospital after discharge from the delivery-associated hospitalization	From discharge from the delivery-associated hospitalization to 6 weeks postpartum
Neonatal hospital readmission	Admission of a neonate to the hospital after discharge from the hospital after birth	Birth to 6 weeks of life

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Heart Association; ConnectionHealth; Memora Health
• Investigators: Principal Investigator: Rachel Sinkey, MD, University of Alabama at Birmingham; Principal Investigator: Wally Carlo, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy outcomes; Health inequities
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: 300013085; 22HERNPMI985239 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No