The Mom and Infant Outcomes (MOMI) Study
1 other identifier
interventional
384
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
February 13, 2026
February 1, 2026
3.3 years
February 7, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Change in Life's Essential 8 (LE8) Composite Score
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
Baseline (T1) to 6 months postpartum (T2)
Change in Life's Essential 8 (LE8) Composite Score
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
6 months postpartum (T2) to 12 months postpartum (T3)
Change in Life's Essential 8 (LE8) Composite Score
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
Baseline (T1) to 12 months postpartum (T3)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
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).
Baseline (T1) to 6 months postpartum (T2)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
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).
6 months postpartum (T2) to 12 months postpartum (T3)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
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).
Baseline (T1) to 12 months postpartum (T3)
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
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).
Baseline (T1) to 6 months postpartum (T2)
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
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).
6 months postpartum (T2) to 12 months postpartum (T3)
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
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).
Baseline (T1) to 12 months postpartum (T3)
Study Arms (2)
Intervention
EXPERIMENTALMOMI 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.
Enhanced Usual Care (EUC)
ACTIVE COMPARATORUsual 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.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 7, 2024
First Posted
February 26, 2024
Study Start
June 27, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be made available at the time of associated publications, or the end of the performance period, whichever comes first. Data and Specimen Hub (DASH) considers submitted datasets to be permanently available.
- Access Criteria
- All requests for data through DASH is routed through the National Institute of Child Health and Human Development (NICHD) DASH Data and Biospecimen Access Committee. This committee reviews these requests and determines whether the proposed use is scientifically and ethically appropriate and does not conflict with data use limitations identified by the submitting institution. If deemed necessary, the committee will obtain additional approvals from the study-specific entity, such as the Multiple Principle Investigators (MPIs).
In accordance with the NIH Policy for Data Management and Sharing, we've carefully considered the data expected to be generated and the best approach to maximize the appropriate sharing of scientific data while also protecting the privacy of human subjects participating in research. We expect remnant biospecimens to be minimal after study execution and will therefore not submit biospecimens. Also of note, obstetric complications, postnatal complications, severe maternal morbidity (SMM), and pregnancy-related mortality (PRM) are rare occurrences. Details surrounding this information are publicly available in birth and death certificates and could be aligned with other information to identify a research participant. Thus, to protect participant privacy, we do not plan to share raw data but will produce collapsed variables for data sharing.