Transforming Maternal Mental Health Care

NCT07766174 | Recruiting

• 1 other identifier: 197038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this pilot study is to assess the feasibility of a RCT comparing Lōvu-augmented with usual prenatal care at UU. This would be a critical next step toward our long-term goal to identify technology-based interventions to improve maternal mental health in the Intermountain West. Our central hypothesis is that Lōvu will be both feasible and have high patient and clinician satisfaction, and that Lōvu-generated data will be a promising substrate for AI-based mental health risk stratification.

Conditions

Perinatal Mental Health

Keywords

Pregnant; Mental Health Check-Ins and Support; App; Care Navigator; Real-Time Vital Signs Data; Nutrition and Wellness Guidance; Education and Birthing Support; Exercise and Pelvic Floor Rehab

Outcome Measures

Primary Outcomes (1)

• Feasibility Outcomes

  Recruitment rate and retention rate at 12 months

  12 Months

Secondary Outcomes (4)

• Mental Health Screening Completion & Clinical Care Metrics

  12 Months

• Care Utilization

  12 Months

• Satisfaction & Usability

  12 Months

• AI Preparation

  12 Months

Study Arms (2)

Lōvu-Augmented Arm

EXPERIMENTAL

The intervention is pragmatic in that the only thing patients are actually asked to do is enroll in Lovu, which is facilitated by the research and clinical personnel after randomization. After enrollment, they are not specifically instructed to do anything accept engage with Lovu as prompted (e.g. in response to reminders to measure BP and submit perinatal depression screening questionnaires) and to use Lovu as a resource for questions and concerns. The data generated by the participant's engagements with Lovu (vital sign measurements, questions, concerns, screening results) will be summarized and transmitted to the clinical team on a weekly basis ), which the team can make use of in clinical care. An example of a clinical impact would be that home BP monitoring with automated transmission of data to the clinical team can improve early detection of preeclampsia and other pregnancy complications.

Behavioral: Lōvu platform

Standard Care Arm

ACTIVE COMPARATOR

Mental health screening via PHQ-9, GAD-7, EPDS, and NIDA Quick Screen (these are all validated surveys) at least three times during your pregnancy: early in pregnancy, at least once later in pregnancy, and then at least once in the postpartum period.

Behavioral: Standard Care Arm

Interventions

Lōvu platform BEHAVIORAL

Standard prenatal care + Lōvu platform. Participant receives a Bluetooth-enabled scale, BP cuff, and handheld fetal Doppler. Orientation to Lōvu app and device use. Lōvu-generated data (e.g., weight, BP, HR) will be visible to the Lovu team and sent to the UU clinical team weekly Participant-reported outcomes (satisfaction, usability) collected via System Usability Scale (SUS)

Lōvu-Augmented Arm

Standard Care Arm BEHAVIORAL

Standard prenatal care per UU clinical protocols Mental health screening via PHQ-9, GAD-7, EPDS, and NIDA Quick Screen at standard intervals (these are all validated surveys) Data collected from EHR.

Standard Care Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant people receiving care at University of Utah Clinics
• Less than 14 weeks gestation at enrollment

You may not qualify if:

• Patients enrolled in other studies utilizing remote monitoring

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Nathan Blue, MD, MPh

  University of Utah, Department of OBGYN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Christensen

CONTACT

801-581-8425; kelly.christensen@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: Participants will be recruited and randomized into two different groups running in parallel to each other

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2032
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)