MedPath

Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial

Not Applicable
Active, not recruiting
Conditions
Blood Pressure
Maternal Health
Interventions
Other: Usual Care
Behavioral: PARITY
Registration Number
NCT05802615
Lead Sponsor
University of Nebraska
Brief Summary

This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness.

Detailed Description

The overall objective of this study is to determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Black race
  • Pregnant with gestational age 20-28 weeks at enrollment
  • Ability to read and write in English language
  • Planning to give birth at a healthcare facility & receive obstetrical care with a healthcare record
  • Reside within 20 minutes of the Lincoln/Omaha, NE metro area
  • Owns a smartphone with internet access
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlUsual CareParticipants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.
PARITYPARITYParticipants will take part in the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program which is community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.
PARITYUsual CareParticipants will take part in the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program which is community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.
Primary Outcome Measures
NameTimeMethod
Maternal Blood Pressure6-12 weeks postpartum

Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).

Feasibility, AttritionCompletion of Study (~24 months)

Percentage of eligible individuals who complete the data

Feasibility, EnrollmentBaseline

Percentage of eligible individuals who agree to participate in the trial

Feasibility, AdherenceCompletion of Study (~24 months)

Number of intervention sessions completed by study participants

Secondary Outcome Measures
NameTimeMethod
Gestational Weight Gain20 weeks, 36 weeks, Birth, 6 weeks postpartum.

Amount of weight gained in pounds

Delivery ModalityBirth (approximately 36-42 weeks)

Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)

Trial Locations

Locations (1)

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

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