The Mom and Infant Outcomes (MOMI) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
MOMI PODS
BehavioralMOMI 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)
BehavioralUsual 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.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual Care (EUC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (T1) to 6 months postpartum (T2)2
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
Time frame
6 months postpartum (T2) to 12 months postpartum (T3)3
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
Time frame
Baseline (T1) to 12 months postpartum (T3)4
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).
Time frame
Baseline (T1) to 6 months postpartum (T2)Sponsors and contacts
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Source ClinicalTrials.gov