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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Maternal Health
• Intervention / Treatment: Behavioral: PARITY; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other: Usual Care; Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.
Placebo Comparator: Control; Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.	Other: Usual Care; Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Intake	Nutritional intake will be measured with the Multifactor Screener, 2000 as used in the Observing Protein and Energy Nutrition (OPEN) Study. This instrument measures approximate intakes of fruits and vegetables, percentage energy from fat, and fiber. Respondents report how frequently they consume foods in 16 categories and type of milk consumed.	Baseline, 6-12 weeks postpartum
Physical Activity	Physical activity will be measured with the International Physical Activity Questionnaire short-form (IPAQ-SF). The IPAQ-SF consists of 9 items and provides information on the time spent walking, in vigorous and moderate intensity activity and in sedentary activity.	Baseline, 6-12 weeks postpartum
Sleep quality	Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI. The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score.	Baseline, 6-12 weeks postpartum
Healthcare Adherence	Healthcare adherence will be measured by number of healthcare appointments measured in the medical record.	Pregnancy continuum, measured at 12 weeks postpartum retrospectively via the medical record
Self-efficacy	Self-efficacy will be measured using the GSE General Self Efficacy (GSE) Scale: The GSE is a one-dimensional self-report measure that features a 10-item questionnaire assessing the optimistic self-beliefs of individuals to cope with a variety of difficult demands in life. The response options are presented along a 4-point Likert scale for each item.	Baseline, 6-12 weeks postpartum
Social support	Social support will be measured with the 10 item Social Provisions Scale (SPS-10). The SPS-10 assesses five forms of social provisions: attachment, guidance, social integration, reliable alliance, and reassurance of worth. Each item is rated on a four-point Likert scale.	Baseline, 6-12 weeks postpartum
Problem-solving	Problem solving will be measured with the Problem-Solving Inventory (PSI). The PSI measures how well individuals make decisions and their problem-solving abilities. The PSI includes 32 items using a 6-point Likert scale.	Baseline, 6-12 weeks postpartum
Motivation	Motivation will be measured with the Self-Motivation Inventory (SMI). The SMI is a 40 item 5 point Likert scale.	Baseline, 6-12 weeks postpartum
Resilience	Resilience will be measured using the 10 item Connor-Davidson Resilience Scale (CD-RISC 10). The CD-RISC 10 a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale.	Baseline, 6-12 weeks postpartum
Self-Regulation	Self-Regulation will be measured with the index of self-regulation (ISR). The ISR is a nine-item scale that measures level of self-regulation for health behavior change. Respondents rate items on a 5-point Likert scale.	Baseline, 6-12 weeks postpartum
Discrimination	Discrimination will be measured using the Everyday Discrimination Scale (EDS). The EDS measures frequency of chronic and routine unfair treatment in everyday life. Respondents are asked to report how often they experience unfair treatment in their day-to-day life on a 6-point Likert scale.	Baseline, 6-12 weeks postpartum
Neighborhood	Neighborhood will be assessed using the Neighborhood Collective Efficacy - Community Cohesion and Informal Social Control protocol. This protocol includes 10 Likert-style questions from the Project on Human Development in Chicago Neighborhoods (PHDCN). The Social Cohesion and Informal Social Control subscales include five items each.	Baseline
Acceptability and Experience	Select intervention participants only (10-15). Qualitative interview to discuss acceptability and experience with the intervention.	12 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Elizabeth K Mollard, PhD, University of Nebraska

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): August 6, 2025
• Study Completion (Actual): August 6, 2025

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Public Health; Environment and Public Health; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Epidemiologic Factors; Reproductive History; Parity
• Other Study ID Numbers: 0076-23-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No