upREACH Home Visitation for Pregnancy

(upREACH Trial)

Overseen By Cary M Cain, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Non-English/Spanish speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new home visitation program, the upREACH Home Visitation Program, can help pregnant women connect to community resources, feel more confident in managing their health, and reduce stress compared to regular care. The program includes home visits from non-nurse visitors who provide support and resources to help prepare for the baby. Suitable candidates for this trial are English or Spanish-speaking women who receive care at Harris Health obstetric clinics and are pregnant or recently gave birth. Participants will complete surveys about their experiences before and after the baby arrives. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance support for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on home visitation services rather than medication changes.

What prior data suggests that the upREACH Home Visitation Program is safe?

Research has shown that home visitation programs can improve health habits during pregnancy, increase birth weight, and reduce child abuse and emergency visits. The upREACH Home Visitation Program offers similar benefits. Studies indicate that participants generally find these programs safe and well-received.

Participants in similar programs often report feeling more connected to resources and supported during pregnancy. Trained home visitors, who are not nurses, conduct the visits, focusing on providing resources, support, and education rather than medical care. This approach makes the program low-risk and generally free from negative effects.

In summary, the upREACH Home Visitation Program aims to make pregnancy and parenting a more supported and informed experience. Safety concerns are minimal, and the program focuses on helping participants connect with the services they need. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the upREACH Home Visitation Program because it offers a hands-on, personalized approach to supporting pregnant individuals. Unlike standard prenatal care that primarily focuses on medical check-ups, this program provides in-home visits where support extends beyond medical needs to include social and emotional well-being. Home visitors work closely with participants to identify and prioritize their unique needs, facilitate access to community resources, and empower them with information to advocate for their health and their baby's future. This holistic approach aims to improve outcomes by addressing broader determinants of health that are often overlooked in traditional care settings.

What evidence suggests that the upREACH Home Visitation Program is effective for improving maternal health and reducing stress?

Research has shown that home visitation programs, such as the upREACH Home Visitation Program, can improve health habits during pregnancy. These programs help babies be born at healthier weights and reduce cases of child abuse and emergency room visits. Studies also indicate that home visits lead to better infant health and support maternal well-being. These programs assist families in preparing for their newborns and connecting them to local resources. Overall, home visitation programs effectively improve the health of both mothers and children. ^{2 3 4 5 6}

Who Is on the Research Team?

Cary M Cain, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum women within 3 weeks after giving birth, who are patients at Harris Health Clinic obstetric clinics and can speak and read English or Spanish. Women not receiving care from these clinics, those not pregnant or over 4 weeks postpartum, or unable to understand English/Spanish cannot join.

Inclusion Criteria

You are currently receiving care for pregnancy at Harris Health Clinic.

I can speak and read either English or Spanish.

You are pregnant or gave birth within the past 3 weeks.

Exclusion Criteria

I cannot speak or read English or Spanish.

Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics

I am not pregnant or it has been more than 4 weeks since I gave birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive at least 1 prenatal and 1 postpartum home visit by a non-nurse home visitor to provide resources and tools for preparing for their baby.

2 months

At least 2 home visits

Postpartum Survey

All participants complete a second round of electronic surveys at approximately 2 months postpartum.

1 week

Follow-up

Participants are monitored for health self-efficacy, trust in institutions, appointment adherence, linkages to community resources, and maternal stress.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• upREACH Home Visitation Program

Trial Overview The study tests a new home visitation program called upREACH against standard clinic care. It aims to connect participants with community resources, boost health confidence, and reduce stress. Outcomes like infant health and service use will be compared between the two groups.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Demographic and baseline measures will be obtained from the participants electronically. The participant will receive at least 1 prenatal home visit and at least 1 postpartum home visit. During the visits, the home visitor will review the screening assessments that were completed at baseline, identify health and social needs (including but not limited to referrals to substance use treatment providers, domestic violence hotline/shelters, mental health providers, applications for public assistance, and basic needs provision),work with the client to prioritize their needs, assist with applications and connections to community resources, support the participant in communicating with medical and social service providers, and provide education to help the participant advocate for their health, think ahead for after delivery (prenatal), and understand infant health and safety. At 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.

Group II: Control Group Active Control 1 Intervention

Demographic and baseline measures will be obtained from the participants electronically through REDCap surveys. The participants will receive standard care from the obstetric clinic. At approximately 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Texas Department of Family Protective Services

Collaborator

Trials

1

Recruited

450+

Published Research Related to This Trial

Clients in the Wisconsin Health Department's Prenatal Care Coordination program reported high satisfaction with the services, primarily valuing the supportive nurse-client relationship and the information provided.

Most clients entered the program without specific expectations, indicating that the program's effectiveness may rely more on the quality of support and resources rather than pre-defined goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. Heitzman, M., Weitzel, J., Kroll, S., et al.[2020]

Home-visitation programs for socially disadvantaged women and children can significantly improve maternal health behaviors, birth outcomes, and child development, while also reducing child abuse and hospital visits.

The most effective programs involved nurses who started visits during pregnancy, maintained frequent contact, and focused on addressing behavioral and psychosocial factors, particularly for families at higher risk due to poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? Olds, DL., Kitzman, H.[2022]

Postnatal home-based support programs for socially disadvantaged mothers show potential benefits, such as a trend towards reduced child injury rates and increased likelihood of complete well-child immunizations, based on a review of 11 studies involving 2992 families.

While the results suggest no significant risks associated with these programs, the findings on child abuse and neglect were inconclusive due to differences in how families were monitored, indicating a need for careful interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Home-based social support for socially disadvantaged mothers. Hodnett, ED., Roberts, I.[2020]

Home visits by nurses during pregnancy significantly reduced the incidence of pregnancy-induced hypertension among low-income women, with 13% of those receiving visits affected compared to 20% in the control group.

The program also led to fewer healthcare encounters for childhood injuries and lower rates of subsequent pregnancies, indicating positive outcomes for maternal and child health, although it did not impact preterm delivery, low birth weight, or children's developmental and behavioral outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. Kitzman, H., Olds, DL., Henderson, CR., et al.[2022]

Recent urban home care programs have been developed to address infant mortality and morbidity in the U.S. by providing comprehensive prenatal and infancy home visitation services.

These programs enhance maternal-child health and family functioning by creating a supportive link between families and their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women and children. Infant mortality, urban programs, and home care. Struk, CM.[2005]

Long-term participants in a home visitation program for high-risk pregnant women were more likely to be African American, married, nonsmokers, and enrolled during their second trimester, indicating specific demographic factors that influence program retention.

Women who had greater emotional and instrumental support needs were more likely to continue participating in the program, suggesting that addressing social support can enhance engagement in home visitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors predicting completion of a home visitation program by high-risk pregnant women: the North Carolina Maternal Outreach Worker Program. Navaie-Waliser, M., Martin, SL., Campbell, MK., et al.[2019]

A program of prenatal and early childhood home visitation by nurses significantly reduced verified reports of child abuse and neglect among participating women, with 0.29 reports compared to 0.54 in the comparison group over 15 years (P<.001).

The intervention also led to fewer subsequent births and reduced reliance on welfare, with nurse-visited women having an average of 1.3 subsequent births compared to 1.6 in the comparison group, and significantly fewer arrests reported (0.18 vs 0.58) over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. Olds, DL., Eckenrode, J., Henderson, CR., et al.[2022]

Postnatal home-based support programs for socially disadvantaged mothers show a trend towards reduced child injury rates, although this finding was not statistically significant, indicating potential benefits in safety.

These programs also appear to improve health outcomes, as babies receiving additional support were more likely to have complete well-child immunizations, suggesting enhanced access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based social support for socially disadvantaged mothers. Hodnett, ED., Roberts, I.[2018]

Participation in Michigan's Maternal Infant Health Program (MIHP) significantly reduced the odds of low birth weight and preterm births among black women, particularly when they enrolled and were screened by the second trimester and had at least three additional prenatal contacts.

The MIHP also showed similar benefits for participants of other races, indicating that enhanced prenatal care programs can effectively improve birth outcomes in diverse, disadvantaged populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A statewide Medicaid enhanced prenatal care program: impact on birth outcomes. Roman, L., Raffo, JE., Zhu, Q., et al.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06133829/upreach-perinatal-home-visitation-program

upREACH Perinatal Home Visitation Program The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) ...

2. withpower.com withpower.com/trial/phase-pregnant-state-11-2023-b68ba

upREACH Home Visitation for Pregnancy Research shows that home visitation programs can improve health behaviors during pregnancy, increase birth weight, and reduce child abuse and emergency visits.

3. apha.confex.com apha.confex.com/apha/2025/meetingapi.cgi/Paper/578524?filename=2025_Abstract578524.pdf&template=Word

Abstract Background: Home visitation programs (HVPs) have demonstrated effectiveness in reducing child maltreatment, improving infant health, promoting positive ...

4. bcm.edu bcm.edu/departments/pediatrics/divisions-and-centers/public-health-pediatrics/research-and-programs

Research and Programs upREACH+ is a short-term perinatal home visitation program to help families prepare to bring home their newborn, support maternal health and well-being ...

5. mchb.hrsa.gov mchb.hrsa.gov/programs-impact/maternal-infant-early-childhood-home-visiting-miechv-program

Maternal, Infant, and Early Childhood Home Visiting (MIECHV ... The MIECHV Program helps pregnant women and parents of young children improve health and well-being for themselves and their families.

6. ctv.veeva.com ctv.veeva.com/study/upreach-perinatal-home-visitation-program

upREACH Perinatal Home Visitation Program The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) ...