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

Not Applicable

Active, not recruiting

• Conditions: Blood Pressure; Maternal Health

• 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.

Study Timeline

• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-04-05
• Study Start: 2023-04-06
• Study First Posted: 2023-04-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-07
• Study Completion: 2025-07

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

Primary Outcome Measures

Name	Time	Method
Maternal Blood Pressure	6-12 weeks postpartum	Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (\>140/90); Severe hypertension (\>160/110).
Feasibility, Attrition	Completion of Study (~24 months)	Percentage of eligible individuals who complete the data
Feasibility, Enrollment	Baseline	Percentage of eligible individuals who agree to participate in the trial
Feasibility, Adherence	Completion of Study (~24 months)	Number of intervention sessions completed by study participants

Secondary Outcome Measures

Name	Time	Method
Delivery Modality	Birth (approximately 36-42 weeks)	Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)
Gestational Weight Gain	20 weeks, 36 weeks, Birth, 6 weeks postpartum.	Amount of weight gained in pounds

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States