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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Placebo Comparator | Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Participants must be pregnant females
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth K Mollard, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39116423 | Derived | 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. |
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| ID | Term |
|---|---|
| D010298 | Parity |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D011247 | Pregnancy |
| D012098 | Reproduction |
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| Usual Care | Other | Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy. |
|
| Completion of Study (~24 months) |
| Birth (approximately 36-42 weeks) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Acceptability and Experience | Select intervention participants only (10-15). Qualitative interview to discuss acceptability and experience with the intervention. | 12 weeks postpartum |
| D017584 | Reproductive History |
| D015981 | Epidemiologic Factors |
| D011634 | Public Health |
| D004778 | Environment and Public Health |