Perinatal Mental HealthIUFUNCT07766174
Transforming Maternal Mental Health Care
A study testing Lōvu platform in people with Perinatal Mental Health, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mental Health
- What is being tested?
- Lōvu platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant people receiving care at University of Utah Clinics
- Less than 14 weeks gestation at enrollment
Who cannot join
- Patients enrolled in other studies utilizing remote monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Kelly Christensen, 801-581-8425, kelly.christensen@hsc.utah.edu
Valerie Joseph, valerie.joseph@hsc.utah.edu
About this study
Official title: Transforming Maternal Mental Health Care Using Innovative Digital Solutions for the Intermountain West
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.
Read the detailed description
Collectively, perinatal mental health disorders impact 20% of pregnancies in the U.S. and are the leading cause of pregnancy-related mortality, contributing to 23% of deaths. In the U.S., 50-75% of perinatal depression (PND) is undiagnosed and PND is untreated in nearly 85%. This is a result, in part, of the systematic underfunding of investigations into maternal mental health. The critical relevance of this reality for "Women Across the Lifespan" could not be more pressing than in Utah and the Intermountain West, where expanding maternity care deserts limit access to mental health care, and suicide rates are 57% above the national average. The traditional prenatal care paradigm does not address maternal mental health needs. It utilizes relatively wide intervals between prenatal visits during the first three quarters of pregnancy-a time of substantial need for education, psychosocial support, and mental health services-only to culminate in a 'care cliff' postpartum, when the risk of mental health crises and maternal mortality is highest.
Technology has enabled remote visits, but telehealth implementations remain anchored to the traditional prenatal care model and consist of two elements: virtual rather than in-person visits, and EHR-based electronic messaging. This amounts to a "worst of both worlds", in which diluted personal connection and the escalating burden of e-messaging contribute to clinician burnout while the core deficiencies of the traditional paradigm remain. Thus, there is a critical need for novel approaches to prenatal care that more fully deliver on the promise of technology to 1) increase patient access and support, 2) reduce clinician burnout, and 3) improve maternal and newborn outcomes.
Aim 1: Assess the feasibility of a randomized, controlled trial comparing usual vs. Lōvu-augmented prenatal care among N=50 pregnant patients. Feasibility will be defined as the successful recruitment of > 50% of patients approached and 90% participant retention for the 12-month study period.
Aim 2: Assess mental health screening completion, care utilization, and user satisfaction in Lovu-augmented vs usual care. Investogators will assess the following outcomes: for clinical care: participant completion of PHQ-9 (PND), GAD-7 (anxiety), NIDA quick screen (substance use), and time to mental health referral and first visit; for utilization: burden of patient-generated e-messages and phone calls to the UU MFM clinic; satisfaction: telehealth usability questionnaire12 and telemedicine satisfaction questionnaire;13 system usability scale.14
Aim 3: Utilize pilot study data to inform the future development of a novel AI-based mental health early warning and referral system. Investigators will 1) harmonize data from the user app, digital sensors, UU electronic health records (EHR) and 2) develop streamlined data transfer and harmonization workflows.
- Conditions
- Perinatal Mental Health
- Being tested
- Lōvu platform, Standard Care Arm
- 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
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lōvu platformBehavioural
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 ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, 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. Receives: 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 the pregnancy: early in pregnancy, at least once later in pregnancy, and then at least once in the postpartum period. Receives: Behavioral: Standard Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes
Recruitment rate and retention rate at 12 months
Measured: 12 Months
Secondary outcomes (4)
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.
Measured: 12 Months
Care Utilization
Counts of e-messages and phone calls compared between arms using non-parametric t-test such as Mann Whitney U.
Measured: 12 Months
Satisfaction & Usability
Continuous scale scores compared using t-tests or non-parametric equivalents if distributions are non-normal
Measured: 12 Months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited and randomized into two different groups running in parallel to each other
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Blue, University of Utah
- Investigators
- Nathan Blue, MD, MPh, Principal investigator, University of Utah, Department of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766174
- Sponsor's protocol ID
- 197038
- Acronym
- IUFU
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Maternal Mental Health Care Using Innovative Digital Solutions for the Intermountain West
- ClinicalTrials.gov ID
- NCT07766174
- Acronym / sponsor ID
- IUFU / 197038
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Collectively, perinatal mental health disorders impact 20% of pregnancies in the U.S. and are the leading cause of pregnancy-related mortality, contributing to 23% of deaths. In the U.S., 50-75% of perinatal depression (PND) is undiagnosed and PND is untreated in nearly 85%. This is a result, in part, of the systematic underfunding of investigations into maternal mental health. The critical relevance of this reality for "Women Across the Lifespan" could not be more pressing than in Utah and the Intermountain West, where expanding maternity care deserts limit access to mental health care, and suicide rates are 57% above the national average. The traditional prenatal care paradigm does not address maternal mental health needs. It utilizes relatively wide intervals between prenatal visits during the first three quarters of pregnancy-a time of substantial need for education, psychosocial support, and mental health services-only to culminate in a 'care cliff' postpartum, when the risk of mental health crises and maternal mortality is highest.
Technology has enabled remote visits, but telehealth implementations remain anchored to the traditional prenatal care model and consist of two elements: virtual rather than in-person visits, and EHR-based electronic messaging. This amounts to a "worst of both worlds", in which diluted personal connection and the escalating burden of e-messaging contribute to clinician burnout while the core deficiencies of the traditional paradigm remain. Thus, there is a critical need for novel approaches to prenatal care that more fully deliver on the promise of technology to 1) increase patient access and support, 2) reduce clinician burnout, and 3) improve maternal and newborn outcomes.
Aim 1: Assess the feasibility of a randomized, controlled trial comparing usual vs. Lōvu-augmented prenatal care among N=50 pregnant patients. Feasibility will be defined as the successful recruitment of > 50% of patients approached and 90% participant retention for the 12-month study period.
Aim 2: Assess mental health screening completion, care utilization, and user satisfaction in Lovu-augmented vs usual care. Investogators will assess the following outcomes: for clinical care: participant completion of PHQ-9 (PND), GAD-7 (anxiety), NIDA quick screen (substance use), and time to mental health referral and first visit; for utilization: burden of patient-generated e-messages and phone calls to the UU MFM clinic; satisfaction: telehealth usability questionnaire12 and telemedicine satisfaction questionnaire;13 system usability scale.14
Aim 3: Utilize pilot study data to inform the future development of a novel AI-based mental health early warning and referral system. Investigators will 1) harmonize data from the user app, digital sensors, UU electronic health records (EHR) and 2) develop streamlined data transfer and harmonization workflows.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be recruited and randomized into two different groups running in parallel to each other
| Arm | Type | Receives |
|---|---|---|
| Lōvu-Augmented Arm | Experimental | Behavioral: Lōvu platformThe 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. |
| Standard Care Arm | Active comparator | Behavioral: Standard Care ArmMental 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant people receiving care at University of Utah Clinics
- Less than 14 weeks gestation at enrollment
Key exclusion criteria (1 listed)
- Patients enrolled in other studies utilizing remote monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lōvu platformStandard 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) | Behavioural | Lōvu-Augmented Arm |
| Standard Care ArmStandard 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. | Behavioural | Standard Care Arm |
Primary outcome
Feasibility Outcomes
Time frame: 12 Months
Recruitment rate and retention rate at 12 months
4 secondary outcomes
Mental Health Screening Completion & Clinical Care Metrics
Time frame: 12 Months
Care Utilization
Time frame: 12 Months
Satisfaction & Usability
Time frame: 12 Months
AI Preparation
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Blue, MD, MPh principal investigator
University of Utah, Department of OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lōvu platform in people with Perinatal Mental Health, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Christensen (801-581-8425, kelly.christensen@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.