PregnancyupREACHNCT06133829
upREACH Perinatal Home Visitation Program
A study testing upREACH Home Visitation Program in people with Pregnancy and Postpartum, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Postpartum
- What is being tested?
- upREACH Home Visitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
- Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
- Speak and read English or Spanish language.
Who cannot join
- Unable to speak or read English or Spanish language
- Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
- Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Harris Health/Baylor College of Medicine
Houston, Texas, 77047
About this study
Official title: upREACH Perinatal Home Visitation Program Randomized Controlled Trial
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) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.
Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.
Read more
For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.
Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.
Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.
- Conditions
- Pregnancy, Postpartum
- Being tested
- upREACH Home Visitation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upREACH Home Visitation ProgramBehavioural
upREACH is a brief perinatal home visitation program delivered by community health workers or similarly qualified personnel. The mission statement of the program is: Families are prepared to bring home their newborn to a safe, stable, and nurturing environment, and have access to tools, resources, and knowledge that promote family health and well-being. Through the program, families will receive a minimum of 2 home visits during pregnancy and/or postpartum from a home visitor (community health worker (CHW) or similarly qualified personnel). The home visitor will assess each family's strengths and needs so they may provide tailored support and brief education to promote maternal health and self-care, infant health and safety, and connection to and knowledge of resources (community orientation).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: upREACH Home Visitation Program |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkages to Community Resources
Measured by Family Resource Scale (higher score shows that resources are more adequate)
Measured: through study completion, an average of 5 months
Health Self-Efficacy
Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)
Measured: through study completion, an average of 5 months
Maternal Stress
Perceived Stress Scale (higher scores indicate higher levels of stress)
Measured: through study completion, an average of 5 months
Secondary outcomes (2)
Trust in Institutions
Measured by Trust in Institutions Instrument (higher scores indicate higher trust)
Measured: through study completion, an average of 5 months
Appointment Adherence
Medical Chart Review of number of appointments attended with Obstetric and Gynecological (OB/GYN) and Pediatric Providers and Self-Report by the participant number of appointments with OB/GYN and Pediatric Appointments
Measured: up to one year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Jan 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cary Cain, Baylor College of Medicine
- Investigators
- Cary M Cain, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133829
- Sponsor's protocol ID
- H-53998
- Other IDs
- 62823-S1
- Acronym
- upREACH
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual level data will only be available to the researchers and sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- upREACH Perinatal Home Visitation Program Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06133829
- Acronym / sponsor ID
- upREACH / H-53998
- Conditions
- Pregnancy, Postpartum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.
Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.
For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.
Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.
Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: upREACH Home Visitation ProgramDemographic 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. |
| Control Group | No 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 may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
- Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
- Speak and read English or Spanish language.
Key exclusion criteria (3 listed)
- Unable to speak or read English or Spanish language
- Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
- Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upREACH Home Visitation ProgramupREACH is a brief perinatal home visitation program delivered by community health workers or similarly qualified personnel. The mission statement of the program is: Families are prepared to bring home their newborn to a safe, stable, and nurturing environment, and have access to tools, resources, and knowledge that promote family health and well-being. Through the program, families will receive a minimum of 2 home visits during pregnancy and/or postpartum from a home visitor (community health worker (CHW) or similarly qualified personnel). The home visitor will assess each family's strengths and needs so they may provide tailored support and brief education to promote maternal health and self-care, infant health and safety, and connection to and knowledge of resources (community orientation). | Behavioural | Intervention Group |
Primary outcome
Linkages to Community Resources
Time frame: through study completion, an average of 5 months
Measured by Family Resource Scale (higher score shows that resources are more adequate)
Health Self-Efficacy
Time frame: through study completion, an average of 5 months
Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)
Maternal Stress
Time frame: through study completion, an average of 5 months
Perceived Stress Scale (higher scores indicate higher levels of stress)
2 secondary outcomes
Trust in Institutions
Time frame: through study completion, an average of 5 months
Appointment Adherence
Time frame: up to one year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. Individual level data will only be available to the researchers and sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cary M Cain, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upREACH Home Visitation Program in people with Pregnancy and Postpartum, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkages to Community Resources (time frame: through study completion, an average of 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.