Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

NCT05940688 | Completed Results DMC

• 2 other identifiers: 30000989722HERNPMI985239
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Infants; Disparities

Keywords

Pregnancy outcomes; Health inequities

Outcome Measures

Primary Outcomes (2)

• Participant Acceptance of Randomization Arm / Intervention

  Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."

  6 weeks postpartum

• Participant Use of Digital Health and/or Community Health Worker Interventions

  Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker.

  From randomization to 6 weeks postpartum

Secondary Outcomes (9)

• Outpatient Perinatal Care Visits

  Randomization to study completion (up to 34 weeks)

• Preterm Birth

  At birth

• Neonatal Birthweight

  At birth

• Cesarean Delivery

  At birth

• Maternal Blood Transfusion

  At birth

Study Arms (4)

Digital Health Intervention

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 their child's first year of life. 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

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

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

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

Location

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rachel Sinkey
• Organization: University of Alabama at Birmingham

rsinkey@uabmc.edu

(205) 934-5612

Study Officials

• Rachel Sinkey, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Assistant Professor

Model Details: Study is a pilot randomized trial (n=40) randomizing eligible participants to usual care (n=10), or usual care plus a digital health intervention (n=10), or usual care plus a community health worker intervention (n=10), or usual care plus both a digital health intervention and a community health worker intervention.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 11, 2023
• Study Start: July 17, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Locations

US (1)