Maternal HealthNCT05802615
Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial
A study testing PARITY in people with Maternal Health and Blood Pressure, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Blood Pressure
- What is being tested?
- PARITY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2023to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Conditions
- Maternal Health, Blood Pressure
- Being tested
- PARITY, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARITYBehavioural
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 CareOther
Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PARITY; Other: Usual Care |
| Control | Placebo comparator | Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Blood Pressure
Participant blood pressure (systolic and diastolic) (continuous) as well as blood pressure classifications hypertension (>140/90); Severe hypertension (>160/110).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6-12 weeks postpartum
Feasibility, Enrollment
Percentage of eligible individuals who agree to participate in the trial
Measured: Baseline
Feasibility, Attrition
Percentage of eligible individuals who complete the data
Measured: Completion of Study (~24 months)
Feasibility, Adherence
Number of intervention sessions completed by study participants
Measured: Completion of Study (~24 months)
Secondary outcomes (2)
Gestational Weight Gain
Amount of weight gained in pounds
Measured: 20 weeks, 36 weeks, Birth, 6 weeks postpartum.
Delivery Modality
Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)
Measured: Birth (approximately 36-42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start6 Apr 2023
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth K Mollard, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802615
- Sponsor's protocol ID
- 0076-23-EP
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39116423
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial
- ClinicalTrials.gov ID
- NCT05802615
- Acronym / sponsor ID
- 0076-23-EP
- Conditions
- Maternal Health, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARITY | Experimental | Behavioral: PARITY, Other: Usual CareParticipants 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. |
| Control | Placebo comparator | Other: Usual CareParticipants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. |
Who may qualify
- Ages
- 19 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARITYThe 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. | Behavioural | PARITY |
| Usual CareParticipants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. | Other | Control, PARITY |
Primary outcome
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).
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).
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).
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).
Feasibility, Enrollment
Time frame: Baseline
Percentage of eligible individuals who agree to participate in the trial
Feasibility, Attrition
Time frame: Completion of Study (~24 months)
Percentage of eligible individuals who complete the data
Feasibility, Adherence
Time frame: Completion of Study (~24 months)
Number of intervention sessions completed by study participants
2 secondary outcomes
Gestational Weight Gain
Time frame: 20 weeks, 36 weeks, Birth, 6 weeks postpartum.
Delivery Modality
Time frame: Birth (approximately 36-42 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 39116423Mollard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Mollard, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARITY in people with Maternal Health and Blood Pressure, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Blood Pressure (time frame: 20 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.