MOMs Chat and Care Study

Last updated: January 6, 2026
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Northwell Pregnancy & Peds Chats

Home Blood Pressure Monitor

Prenatal Telehealth Visits

Clinical Study ID

NCT06335381
24-0131
1R01NR021134-01
  • Ages 18-50
  • Female

Study Summary

The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to reduce risk for SMM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or older,

  • Self-identify as Black/African American or Hispanic/Latina (includes Black + anotherrace; Black or Afro Hispanic/Latina; or Hispanic/Latina),

  • Pregnant, less than 17 weeks gestational age,

  • OB-CMI risk score ≥ 2 and/or history or preeclampsia,

  • English or Spanish as primary language, and

  • Receive care at Northwell Health Physician Partners obstetrics practice site.

Exclusion

Exclusion Criteria:

• Birthing people who are not able to provide informed consent due to cognitive or psychiatric impairment.

If interested in participating in the study, please visit https://www.momschatandcare.com/

Study Design

Total Participants: 674
Treatment Group(s): 5
Primary Treatment: Northwell Pregnancy & Peds Chats
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
June 30, 2028

Study Description

The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). MOMs-HT will consist of close clinical and behavioral health monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support calls with the MOMs team during the prenatal period; and 5 bi-weekly postpartum clinical check-in calls with navigation by the MOMs team up to 6 weeks postpartum. MOMs-LT will also include clinical and behavioral health monitoring via the chatbot along with navigation to services by the MOMs team as needed and 5 bi-weekly postpartum clinical check-in calls with navigation. Participants in both study arms will receive a Fitbit to track engagement in physical activity. SMM at labor and delivery (primary) and SMM-related hospitalizations at 1-month and 1-year postpartum (secondary) will be based on the CDC's 21 indicators with diagnoses extracted from the EHR. Diagnosis of preeclampsia and initiation of treatment (secondary) will also be captured using the EHR. Questionnaires will be administered to measure domains of social support (secondary). Physical activity behaviors (exploratory) will be assessed via survey and wearable activity monitor (i.e., Fitbit). Determinants of implementation will be captured via semi-structured qualitative interviews and discrete process measures.

Connect with a study center

  • Northwell Health

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northwell Health

    Manhasset 5125766, New York 5128638 11030
    United States

    Active - Recruiting

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