NCT06277661 · Ohio State University
The Mom and Infant Outcomes (MOMI) Study
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
MOMI PODS
MOMI PODS is an innovative, dyadic model of PP primary care. Informed by the Chronic Care Model (CCM) and extensive stakeholder engagement, the MOMI PODS suite of services addresses four primary domains, with a focus on preventing PRM and eliminating SES, racial, and ethnic disparities in PRM. First, MOMI PODS is a dyadic model of care, with mothers and infants cared for in tandem throughout the PP year, and beyond. Second, MOMI PODS was strategically designed to facilitate a coordinated obstetric to PP primary care transition. Third, MOMI PODS is delivered in a way that promotes tailored, evidence-based care informed by the obstetric history. Fourth, MOMI PODS systematically integrates clinical and supportive care to concurrently address clinical and psychosocial needs, with MOMI PODS engagement extending beyond the typical referral process to facilitate direct access to needed resources and empower patients.
BEHAVIORAL
Enhanced Usual Care (EUC)
Usual care will be enhanced in by implementing an enhanced PP care handoff as an adaptation of typical institutional discharge procedures. Specifically, under current processes, birthing parents are asked to provide the name of their infant's pediatrician during the L\&D admission, must provide the name of their infant's pediatrician prior to discharge, and are assisted with identifying a pediatrician throughout this process as needed. Alternatively, under current processes, mothers are reminded to seek PP care but not required to identify the location of care or assisted with doing so. As a component of EUC, we'll provide participants with information about our 7 EUC sites and actively assist with identifying their preferred location of care and scheduling PP care. Our research team will also engage with EUC recipients throughout the study period to encourage engagement and study retention through small care packages and hand-written notes, as well as data collection.
Primary outcome measures
Change in Life's Essential 8 (LE8) Composite Score
Time frame: Baseline (T1) to 6 months postpartum (T2)
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=5-\<6 or \>=10; 20=4-\<5; 0=\<4; body mass index (kg/m2): 100=\<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=\>=40; Non-HDL mg/dL: 100=\<130; 60=130-159; 40=160-189; 20=190-219; 0=\>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/\<5.7; 60=No/5.7-6.4; 40=Yes/\<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/\>=10; Blood pressure: 100=\<120/\<80; 75=120-129/\<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=\>=160 or \>=100; -20 if treated
Change in Life's Essential 8 (LE8) Composite Score
Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)
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=5-\<6 or \>=10; 20=4-\<5; 0=\<4; body mass index (kg/m2): 100=\<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=\>=40; Non-HDL mg/dL: 100=\<130; 60=130-159; 40=160-189; 20=190-219; 0=\>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/\<5.7; 60=No/5.7-6.4; 40=Yes/\<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/\>=10; Blood pressure: 100=\<120/\<80; 75=120-129/\<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=\>=160 or \>=100; -20 if treated
Change in Life's Essential 8 (LE8) Composite Score
Time frame: Baseline (T1) to 12 months postpartum (T3)
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=5-\<6 or \>=10; 20=4-\<5; 0=\<4; body mass index (kg/m2): 100=\<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=\>=40; Non-HDL mg/dL: 100=\<130; 60=130-159; 40=160-189; 20=190-219; 0=\>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/\<5.7; 60=No/5.7-6.4; 40=Yes/\<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/\>=10; Blood pressure: 100=\<120/\<80; 75=120-129/\<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=\>=160 or \>=100; -20 if treated
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline (T1) to 6 months postpartum (T2)
We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)
We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline (T1) to 12 months postpartum (T3)
We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline (T1) to 6 months postpartum (T2)
We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)
We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline (T1) to 12 months postpartum (T3)
We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).
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
- To be eligible for the MOMI PODS RCT, individuals will be required to be pregnant, with a current diagnosis or history of one or more of the following reflected in the medical record or by self-report - chronic hypertension (with or without super-imposed preeclampsia); gestational hypertension; preeclampsia; eclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; type 1 diabetes mellitus; type 2 diabetes mellitus; gestational diabetes mellitus (GDM); a depressive disorder (e.g., major depressive disorder, persistent depressive disorder) or anxiety disorder (e.g., generalized anxiety disorder, panic disorder).43-48 Inclusion criteria will also include a singleton pregnancy and medical record documentation or self-report of private or government-sponsored health insurance at the time of enrollment.
Where
- Columbus, Ohio
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 May 14, 2026 · Source of record for eligibility and locations