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

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

Interventions

BEHAVIORAL

Digital Health intervention

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

BEHAVIORAL

Community Health Worker

Health care information delivered via CHW.

BEHAVIORAL

Digital Health Intervention plus Community Health Worker

Health care information delivered via DHI plus CHW

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• ConnectionHealth

  collaborator UNKNOWN

• Memora Health

  collaborator UNKNOWN

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Rachel Sinkey, MD · University of Alabama at Birmingham

• Wally Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2026-07-31

Completion

2027-01-31

Countries

• United States

Study Locations