PARITY Feasibility Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PARITY
|
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
|
Other: Usual Care
Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.
|
Outcome Measures
Primary Outcome Measures
- Maternal Blood Pressure [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 [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 [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 [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 [Baseline]
Percentage of eligible individuals who agree to participate in the trial
- Feasibility, Attrition [Completion of Study (~24 months)]
Percentage of eligible individuals who complete the data
- Feasibility, Adherence [Completion of Study (~24 months)]
Number of intervention sessions completed by study participants
Secondary Outcome Measures
- Gestational Weight Gain [20 weeks, 36 weeks, Birth, 6 weeks postpartum.]
Amount of weight gained in pounds
- Delivery Modality [Birth (approximately 36-42 weeks)]
Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)
Other Outcome Measures
- Nutritional Intake [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.
- Physical Activity [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.
- Sleep quality [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.
- Healthcare Adherence [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.
- Self-efficacy [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.
- Social support [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.
- Problem-solving [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.
- Motivation [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.
- Resilience [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.
- Self-Regulation [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.
- Discrimination [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.
- Neighborhood [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.
- Acceptability and Experience [12 weeks postpartum]
Select intervention participants only (10-15). Qualitative interview to discuss acceptability and experience with the intervention.
Eligibility Criteria
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, and receive obstetrical care with a healthcare record; Reside within 20 minutes of the Lincoln/Omaha, NE metro area; Owns a smartphone with internet access
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
Sponsors and Collaborators
- University of Nebraska
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PARITYFEASIBILITY