Health TrialsbyHealthPanel

Transforming Maternal Mental Health Care

ConditionPerinatal Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant people receiving care at University of Utah Clinics

Less than 14 weeks gestation at enrollment

Disqualifiers

Patients enrolled in other studies utilizing remote monitoring

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Lōvu-Augmented ArmExperimental treatment 1 intervention
Group B: Standard Care ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility Outcomes

Recruitment rate and retention rate at 12 months

Time frame
12 Months

Secondary outcomes

1

Mental Health Screening Completion & Clinical Care Metrics

Proportion of participants completing PHQ-9, GAD-7, NIDA. Time to referral and first mental health visit analyzed using non-parametric t-test such as Mann Whitney U. All surveys have their own scales however investigators are only assessing the proportion of participants who complete them, not the scores themself.

Time frame
12 Months
2

Care Utilization

Counts of e-messages and phone calls compared between arms using non-parametric t-test such as Mann Whitney U.

Time frame
12 Months
3

Satisfaction & Usability

Continuous scale scores compared using t-tests or non-parametric equivalents if distributions are non-normal

Time frame
12 Months
4

AI Preparation

Data integration and variable harmonization will be evaluated descriptively. No AI model training will occur during the pilot, but variables will be characterized by frequency, completeness, and time series properties to inform future modeling.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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