Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
NCT ID: NCT05940688
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-07-17
2024-07-01
Brief Summary
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Detailed Description
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1. To assess the feasibility of the digital health (DHI) and community health worker (CHW) interventions by assessing participant acceptance and use of the intervention.
2. To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion criteria to estimate enrollment duration in the planned trial.
3. To determine the number of prenatal visits and the incidence of some of the maternal and neonatal outcomes (ones with higher prevalence) or surrogate outcomes that will be targeted in the planned factorial design randomized controlled trial. (Data will be collected on all relevant maternal and neonatal outcomes. The randomized feasibility design will allow for effect size estimates of the intervention on the incidence of maternal and neonatal outcomes, which will aid in determining the appropriate target outcomes as well as power calculation of the more definitive 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 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. The objective of this pilot study is to determine if it is feasible to randomize and implement digital health and community health worker interventions.
Design Summary
The investigators will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the existing healthcare system, including existing digital health and community health worker programs from within the EQUATE consortium, to eliminate critical barriers to equitable healthcare access. After seeking input from a Community Advisory Board, these interventions will be refined and deployed for pilot testing. Individuals in Non-Hispanic Black communities at the highest risk of adverse pregnancy outcomes which were historically underrepresented in clinical research due to structural racism will be included. The investigative team employs experts across the community, maternal, and infant health continuum.
For this pilot, 40 eligible participants will be randomized, 10 to usual care, 10 to DHI, 10 to CHW, and 10 to DHI + CHW
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Digital Health Intervention
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.
Digital Health intervention
Health care information delivered via a link in a text message that is then opened in a secure browser.
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 their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
Community Health Worker
Health care information delivered via CHW.
DHI Plus CHW
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
Digital Health Intervention plus Community Health Worker
Health care information delivered via DHI plus CHW
Usual Care
This group will receive routine prenatal care services.
No interventions assigned to this group
Interventions
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Digital Health intervention
Health care information delivered via a link in a text message that is then opened in a secure browser.
Community Health Worker
Health care information delivered via CHW.
Digital Health Intervention plus Community Health Worker
Health care information delivered via DHI plus CHW
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Speaks or writes in languages other than English
* Currently incarcerated
* Fetal demise diagnosed prior to enrollment
* Known major structural chromosomal abnormalities prior to enrollment
16 Years
49 Years
FEMALE
No
Sponsors
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American Heart Association
OTHER
ConnectionHealth
UNKNOWN
Memora Health
UNKNOWN
University of Alabama at Birmingham
OTHER
Responsible Party
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Rachel Sinkey
Assistant Professor
Principal Investigators
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Rachel Sinkey, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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22HERNPMI985239
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300009897
Identifier Type: -
Identifier Source: org_study_id
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