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NCT06277661 · ClinicalTrials.gov registry record · NA
The Mom and Infant Outcomes (MOMI) Study
A NA study of Postpartum Depression and Cardiometabolic Syndrome, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 384
- Enrollment target
- 1
- Study location
NCT06277661: Recruiting NA study of Postpartum Depression and Cardiometabolic Syndrome, sponsored by Ohio State University.
NCT06277661 is a NA study of Postpartum Depression and Cardiometabolic Syndrome that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 384 participants, below the 467-participant average among 47 other Postpartum Depression trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06277661, a NA study of Postpartum Depression and Cardiometabolic Syndrome, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 384 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.
Primary Outcome
Higher scores=better health (0-100). 0-100 points for each domain. Total divided by 8. Diet (Mediterranean Eating Pattern for Americans score): 100=15-16; 80=12-14; 50=8-11; 25=4-7; 0=0-3; Physical Activity (min. moderate+/week): 100=\>=150; 90=120-149; 80=90-119; 60=60-89; 40=30-59; 20=1-29; 0=0; Nicotine: 100=Never; 75=Former, quit \>=5y; 50=Former, quit 1-\<5y; 25=Former, quit \<1y or vaping; 0=Current; -20 living with indoor smoker; Sleep (avg. hrs./night): 100=7\<9; 90=9-\<10; 70=6-\<7; 40=
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Usual Care (EUC)
- BEHAVIORAL MOMI PODS
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2028-03-01 |
| Phase | NA |
What NCT06277661 shows while recruiting
NCT06277661 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 467-participant average among 47 other Postpartum Depression trials with a reported enrollment target (18% lower).
The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care (EUC) is the first listed.
NCT06277661 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06277661 about?
NCT06277661 is a clinical study titled "The Mom and Infant Outcomes (MOMI) Study". The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery...
What is the current status of trial NCT06277661?
This trial is currently recruiting. It is a NA study. The enrollment target is 384 participants. The study started on 2024-06-27. Estimated completion is 2028-03-01.
What conditions does trial NCT06277661 study?
This clinical trial studies the following conditions: Postpartum Depression, Cardiometabolic Syndrome, Postpartum Anxiety.
What interventions are being tested in trial NCT06277661?
The interventions under investigation include: Enhanced Usual Care (EUC) (BEHAVIORAL), MOMI PODS (BEHAVIORAL).
Who is sponsoring clinical trial NCT06277661?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06277661 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06277661's enrollment target sits among peer trials
384 10th of 47 higher than 38 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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