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Completed

NCT Number: NCT05802615

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.

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Key information

Conditions

Maternal Health Blood Pressure

Age range

19 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

  1. Maternal Blood Pressure

    Time frame: 20 weeks

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

  2. Maternal Blood Pressure

    Time frame: 36 weeks

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

  3. Maternal Blood Pressure

    Time frame: Birth (approximately 36-42 weeks)

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

  4. Maternal Blood Pressure

    Time frame: 6-12 weeks postpartum

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

  5. Feasibility, Enrollment

    Time frame: Baseline

    Percentage of eligible individuals who agree to participate in the trial

  6. Feasibility, Attrition

    Time frame: Completion of Study (~24 months)

    Percentage of eligible individuals who complete the data

  7. Feasibility, Adherence

    Time frame: Completion of Study (~24 months)

    Number of intervention sessions completed by study participants

Secondary outcomes

  1. Gestational Weight Gain

    Time frame: 20 weeks, 36 weeks, Birth, 6 weeks postpartum.

    Amount of weight gained in pounds

  2. Delivery Modality

    Time frame: Birth (approximately 36-42 weeks)

    Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)

Other outcomes

  1. Nutritional Intake

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  2. Physical Activity

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  3. Sleep quality

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  4. Healthcare Adherence

    Time frame: Pregnancy continuum, measured at 12 weeks postpartum retrospectively via the medical record

    Healthcare adherence will be measured by number of healthcare appointments measured in the medical record.

  5. Self-efficacy

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  6. Social support

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  7. Problem-solving

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  8. Motivation

    Time frame: Baseline, 6-12 weeks postpartum

    Motivation will be measured with the Self-Motivation Inventory (SMI). The SMI is a 40 item 5 point Likert scale.

  9. Resilience

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  10. Self-Regulation

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  11. Discrimination

    Time frame: Baseline, 6-12 weeks postpartum

    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.

  12. Neighborhood

    Time frame: Baseline

    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.

  13. Acceptability and Experience

    Time frame: 12 weeks postpartum

    Select intervention participants only (10-15). Qualitative interview to discuss acceptability and experience with the intervention.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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