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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Health, Blood Pressure

Intervention / Treatment
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* Behavioral: PARITY
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PARITY<br>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<br>* 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.<br>Other: Usual Care<br>* Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.<br>|
| Placebo Comparator: Control<br>Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. | Other: Usual Care<br>* Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.<br>|

What is the study measuring?
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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) |