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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802615
• Other study ID #: 0076-23-EP
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: Elizabeth K Mollard, PhD
• Phone: 402-472-3665
• Email: elizabeth.mollard[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 51 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Blood Pressure
• Maternal Health

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Acceptability and Experience	Select intervention participants only (10-15). Qualitative interview to discuss acceptability and experience with the intervention.	12 weeks postpartum
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	Feasibility, Enrollment	Percentage of eligible individuals who agree to participate in the trial	Baseline
Primary	Feasibility, Attrition	Percentage of eligible individuals who complete the data	Completion of Study (~24 months)
Primary	Feasibility, Adherence	Number of intervention sessions completed by study participants	Completion of Study (~24 months)
Secondary	Gestational Weight Gain	Amount of weight gained in pounds	20 weeks, 36 weeks, Birth, 6 weeks postpartum.
Secondary	Delivery Modality	Modality of birth (Vaginal, Cesarean, Assisted Vaginal delivery)	Birth (approximately 36-42 weeks)