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

NCT05802615 | Completed DMC

• 1 other identifier: 0076-23-EP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Health; Blood Pressure

Outcome Measures

Primary Outcomes (7)

• Maternal Blood Pressure

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

  20 weeks

• Maternal Blood Pressure

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

  36 weeks

• Maternal Blood Pressure

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

  Birth (approximately 36-42 weeks)

• Maternal Blood Pressure

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

  6-12 weeks postpartum

• Feasibility, Enrollment

  Percentage of eligible individuals who agree to participate in the trial

  Baseline

• Feasibility, Attrition

  Percentage of eligible individuals who complete the data

  Completion of Study (~24 months)

• Feasibility, Adherence

  Number of intervention sessions completed by study participants

  Completion of Study (~24 months)

Secondary Outcomes (2)

• Gestational Weight Gain

  20 weeks, 36 weeks, Birth, 6 weeks postpartum.

• Delivery Modality

  Birth (approximately 36-42 weeks)

Other Outcomes (13)

• Nutritional Intake

  Baseline, 6-12 weeks postpartum

• Physical Activity

  Baseline, 6-12 weeks postpartum

• Sleep quality

  Baseline, 6-12 weeks postpartum

Study Arms (2)

PARITY

EXPERIMENTAL

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.

Behavioral: PARITY; Other: Usual Care

Control

PLACEBO COMPARATOR

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

Other: Usual Care

Interventions

PARITY 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.

PARITY

Usual Care OTHER

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

Control; PARITY

Eligibility Criteria

• Age: 19 Years - 51 Years
• Gender Eligibility Details: Participants must be pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• 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.

  PMID: 39116423 DERIVED

MeSH Terms

Interventions

Parity

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health

Study Officials

• Elizabeth K Mollard, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 6, 2023
• Study Start: April 6, 2023
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: November 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)