Clinical trial NCT05802615: Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial
Official title: Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Maternal Health
Blood Pressure
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Maternal Blood Pressure
timeFrame: 20 weeks
measure: Maternal Blood Pressure
timeFrame: 36 weeks
measure: Maternal Blood Pressure
timeFrame: Birth (approximately 36-42 weeks)
measure: Maternal Blood Pressure
timeFrame: 6-12 weeks postpartum
measure: Feasibility, Enrollment
timeFrame: Baseline
measure: Feasibility, Attrition
timeFrame: Completion of Study (~24 months)
measure: Feasibility, Adherence
timeFrame: Completion of Study (~24 months)
Secondary outcomes:
measure: Gestational Weight Gain
timeFrame: 20 weeks, 36 weeks, Birth, 6 weeks postpartum.
measure: Delivery Modality
timeFrame: Birth (approximately 36-42 weeks)
Other outcomes:
measure: Nutritional Intake
timeFrame: Baseline, 6-12 weeks postpartum
measure: Physical Activity
timeFrame: Baseline, 6-12 weeks postpartum
measure: Sleep quality
timeFrame: Baseline, 6-12 weeks postpartum
measure: Healthcare Adherence
timeFrame: Pregnancy continuum, measured at 12 weeks postpartum retrospectively via the medical record
measure: Self-efficacy
timeFrame: Baseline, 6-12 weeks postpartum
measure: Social support
timeFrame: Baseline, 6-12 weeks postpartum
measure: Problem-solving
timeFrame: Baseline, 6-12 weeks postpartum
measure: Motivation
timeFrame: Baseline, 6-12 weeks postpartum
measure: Resilience
timeFrame: Baseline, 6-12 weeks postpartum
measure: Self-Regulation
timeFrame: Baseline, 6-12 weeks postpartum
measure: Discrimination
timeFrame: Baseline, 6-12 weeks postpartum
measure: Neighborhood
timeFrame: Baseline
measure: Acceptability and Experience
timeFrame: 12 weeks postpartum
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Elizabeth K Mollard, PhD
role: PRINCIPAL_INVESTIGATOR
References: