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

NCT ID: NCT05802615

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2025-08-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal Health Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PARITY

Participants 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.

Group Type EXPERIMENTAL

PARITY

Intervention Type BEHAVIORAL

The PARITY program reinforces strengths through consistent, community-based Black doula support and protective asset (personal strengths) focused messaging. PARITY promotes wellness-related behaviors (nutrition, physical activity, sleep, and healthcare adherence) and promotes and builds empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) through mobile technology and doula support.

Usual Care

Intervention Type OTHER

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

Control

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PARITY

The PARITY program reinforces strengths through consistent, community-based Black doula support and protective asset (personal strengths) focused messaging. PARITY promotes wellness-related behaviors (nutrition, physical activity, sleep, and healthcare adherence) and promotes and builds empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) through mobile technology and doula support.

Intervention Type BEHAVIORAL

Usual Care

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth K Mollard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Mollard E, Cooper Owens D, Bach C, Gaines C, Maloney S, Moore T, Wichman C, Shah N, Balas M. Protective Assets Reinforced With Integrated Care and Technology (PARITY): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 8;13:e58580. doi: 10.2196/58580.

Reference Type DERIVED
PMID: 39116423 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0076-23-EP

Identifier Type: -

Identifier Source: org_study_id