NCT07766174 · University of Utah
Transforming Maternal Mental Health Care
(IUFU)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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)
BEHAVIORAL
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 measures
Feasibility Outcomes
Time frame: 12 Months
Recruitment rate and retention rate at 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations