Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)

NCT04100577 | Completed

• 4 other identifiers: 2019-0684A536784SMPH\PEDIATRICS\NEWBORN NURSProtocol Version 3/5/2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot project aims to implement and investigate the feasibility and acceptability of a unique community based prenatal care and support model for African American women and infants in Dane County. The model, the "Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)" builds on emerging evidence about how to effectively implement and sustain prenatal care in black communities. It combines three approaches-community-based doula programs; group-based models of prenatal care, such as Centering Pregnancy; and community-based pregnancy support groups-into once monthly group sessions held during the prenatal and immediate postpartum period. The project is based at the Today Not Tomorrow Family Resource Center in Madison's East Side Community Center, and carried out in close collaboration with Project Babies, Harambee Village Doulas, and the African American Breastfeeding Alliance of Dane County, Inc.

Conditions

Infant Mortality; Infant Death; Racial Bias; Prenatal Stress; Prenatal Care; Maternal Child Health; Health Problems in Pregnancy; Adverse Childhood Experiences; Mental Health; Support Groups; Minority Health; Healthcare Disparities; Maternal-child Health Services; Social Determinants of Health; Trust; Physician-Patient Relations; Quality of Care

Keywords

TNT-PISP

Outcome Measures

Primary Outcomes (2)

• Participant recruitment as assessed by percentage of participants enrolled in Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)

  TNT-PISP is aiming to recruit 20 self-identified African American women into the TNT-PISP Pilot. The actual recruitment will be measured as percentage of participants recruited, assuming recruitment of 20 participants per arm as 100%

  2 years

• Retention rate of participants as assessed by percentage of participants adhered to study for 2 years

  Retention rate of participants as assessed by percentage of participants adhered to study for 2 years

  2 years

Secondary Outcomes (5)

• Preliminary Maternal Child Health Outcomes: Birth weight

  At child birth or at 38 week average gestation time whichever will come first

• Preliminary Maternal Child Health Outcomes: Birth gestational age

  At child birth or at 38 week average gestation time whichever will come first

• Percentage of participants breastfed babies at time of birth

  up to 2 years

• Percentage of participants opted for inter-conception care plans

  2 years

• Rate of attendance to 6- week postpartum visit

  6 week postpartam

Study Arms (2)

TNT PISP intervention

EXPERIMENTAL

Participants in TNT PISP intervention group will come to once monthly educational support group sessions and will be additionally enrolled in the community based doula program where they will receive 1 on 1 doula and lactation support throughout their pregnancy, delivery, and postpartum period. They will receive prenatal care clinical visits on their own with their prenatal care provider. In phase 2 of the study, participants will be offered on site prenatal care once per month.

Other: Today Not Tomorrrow Pregnancy and Infant Support Program

Control

NO INTERVENTION

Participants in control group will have no enhanced prenatal care support. They will attend visits on their own with their prenatal care provider and participation in this research study will not interfere with the prenatal care.

Interventions

Today Not Tomorrrow Pregnancy and Infant Support Program OTHER

The Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP) is a collaborative community-based support group uniquely designed to serve black women and infants through once monthly group sessions delivered prenatally and in the immediate postpartum period.

TNT PISP intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant self- identified black women
• Living in Dane County Wisconsin

You may not qualify if:

• Not pregnant or did not deliver within the last year
• Do not self- identify as a black woman

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Partnership Program: collaborator

Study Sites (1)

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Infant Death; Racism; Psychological Well-Being

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior; Social Discrimination; Personal Satisfaction

Study Officials

• Jasmine Y Zapata, MD, MPH

  University of WI School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A longitudinal, quasi-experimental design with two study arms will be used. Study arm 1 will consist of self-identified pregnant black women who are enrolled in the TNT-PISP intervention and Study arm 2 will consist of self-identified pregnant black women who are not enrolled in the TNT-PISP intervention. During the recruitment process, potential study participants will be able to self- select which study arm they would like to be in after each arm is described in detail. Although self-selection is traditionally discouraged in research, given the vulnerable population the investigator will be working with and historic distrust with medical community, investigator believe there is power in giving women of color choice in how they wish to navigate and engage with this study.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: October 3, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)