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

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ClinicalTrials.gov Identifier: NCT04100577
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Wisconsin Partnership Program
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
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 Other: Today Not Tomorrrow Pregnancy and Infant Support Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Addressing Black Infant Mortality in Wisconsin Through a Collaborative Health Equity Approach Through Community Based Group Prenatal Care and Infant Support
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TNT PISP intervention
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
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Participant recruitment as assessed by percentage of participants enrolled in Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP) [ Time Frame: 2 years ]
    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. Retention rate of participants as assessed by percentage of participants adhered to study for 2 years [ Time Frame: 2 years ]
    Retention rate of participants as assessed by percentage of participants adhered to study for 2 years


Secondary Outcome Measures :
  1. Preliminary Maternal Child Health Outcomes: Birth weight [ Time Frame: At child birth or at 38 week average gestation time whichever will come first ]
    Birth weight of baby will be assessed from the medical records in the TNT-PISP group and the control group to assess the effect of the intervention on the preliminary maternal child health outcome.

  2. Preliminary Maternal Child Health Outcomes: Birth gestational age [ Time Frame: At child birth or at 38 week average gestation time whichever will come first ]
    Birth gestational age will be assessed from the medical records in the TNT-PISP group and the control group to assess the effect of the intervention on the preliminary maternal child health outcome.

  3. Percentage of participants breastfed babies at time of birth [ Time Frame: up to 2 years ]
    Percentage of participants breastfed babies at time of birth as per the medical records

  4. Percentage of participants opted for inter-conception care plans [ Time Frame: 2 years ]
    Percentage of participants opted for inter-conception care plans as per the medical records

  5. Rate of attendance to 6- week postpartum visit [ Time Frame: 6 week postpartam ]
    Rate of attendance to 6- week postpartum visit as per the medical records



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100577


Contacts
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Contact: Jasmine Y Zapata, MD, MPH 6082654070 jzapata@pediatrics.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Wisconsin Partnership Program
Investigators
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Principal Investigator: Jasmine Y Zapata, MD, MPH University of WI School of Medicine and Public Health

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04100577    
Other Study ID Numbers: 2019-0684
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
TNT-PISP
Additional relevant MeSH terms:
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Infant Death
Death
Pathologic Processes