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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06510075
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital Health intervention — BEHAVIORAL
    Health care information delivered via a link in a text message that is then opened in a secure browser.
  • Community Health Worker — BEHAVIORAL
    Health care information delivered via CHW.
  • Digital Health Intervention plus Community Health Worker — BEHAVIORAL
    Health care information delivered via DHI plus CHW

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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
  • Experimental: DHI Plus CHW
    This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
  • No Intervention: Usual Care
    This group will receive routine prenatal care services.

Primary Outcome Measure

Weighted Adverse Outcome Score (WAOS) [ Time Frame: [Time Frame: From randomization to 6 weeks postpartum] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Rosylen Quinney
[email protected]
205.934.1309

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By research site
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