Recruiting

Lōvu

Sponsor:

University of Utah

Code:

NCT07766174

Conditions

Perinatal Mental Health

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Lōvu platform

Standard Care Arm

Study Details

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 the long-term goal to identify technology-based interventions to improve maternal mental health in the Intermountain West. The investigator's 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

Study ID

NCT07766174

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2032

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients enrolled in other studies utilizing remote monitoring

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Lōvu-Augmented Arm

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, participants 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.

active comparator: Standard Care Arm

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

Interventions

Lōvu platform

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)

Standard Care Arm

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.

Primary outcome measure

  • Feasibility Outcomes [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Locations

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

More Information

Sponsor

University of Utah

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-31.