Postpartum DepressionNCT06277661
The Mom and Infant Outcomes (MOMI) Study
A study testing MOMI PODS in people with Postpartum Depression and Postpartum Anxiety, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety, Cardiometabolic Syndrome
- What is being tested?
- MOMI PODS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 1 Mar 2028
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will include the presence of a pre-existing, community driven MOMI PODS referral and enrollment into the program, maternal history of a seizure disorder, medical record documentation or self-report of a major complication of the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot. Exclusion criteria will also include the presence of a major genetic disorder among the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to trisomy 13, or trisomy 18 (trisomy 21 is not an exclusion criteria).
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
The Ohio State University
Columbus, Ohio, 43210
Shannon L. Gillespie, PhD, RN, 6142924589, gillespie.175@osu.edu
Sandra Solove, MA, 6142478366, solove.3@osu.edu
About this study
Official title: The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
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.
Read the detailed description
Using this data, the investigators will address the following Specific Aims:
Specific Aim 1: To evaluate the effectiveness of MOMI PODS versus EUC in mitigating cardiometabolic and mental health risk across the PP year. Hypotheses: MOMI PODS (vs. EUC) recipients will show better cardiometabolic and mental health (Primary Outcomes: higher Life's Essential 8 scores, fewer depressive and anxiety symptoms, Secondary Outcomes: fewer emergency visits and hospital readmissions).
Specific Aim 2: To identify the biopsychosocial mechanisms through which MOMI PODS affects PP cardiometabolic and mental health at the individual patient level. Hypotheses: MOMI PODS (vs. EUC) recipients will report better patient-provider relationships and less psychosocial stress and show better stress-responsive endocrine and immune profiles, which will be critical drivers of cardiometabolic and mental health.
Specific Aim 3: To determine if MOMI PODS promosed longitudinal delivery of evidence-based PP care and identify strategies to improve implementation and service outcomes. Hypotheses: MOMI PODS (vs. EUC) recipients will receive clinical and supportive care that is more adherent to evidence-based guidelines. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity and timeliness of clinical and supportive care across MOMI PODS sites.
- Being tested
- MOMI PODS, Enhanced Usual Care (EUC)
- Keywords
- Postpartum, Mental Health, Cardiometabolic Health, Maternal-Infant Health
- Medical subject headings
- Depression, Postpartum, Metabolic Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMI PODSBehavioural
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.
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: MOMI PODS |
| Enhanced Usual Care (EUC) | Active comparator | 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. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (T1) to 12 months postpartum (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start27 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Gillespie, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277661
- Sponsor's protocol ID
- 2023H0305
- Status last verified
- May 2026
- First submitted
- 7 Feb 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
- ClinicalTrials.gov ID
- NCT06277661
- Acronym / sponsor ID
- 2023H0305
- Keywords
- Postpartum, Mental Health, Cardiometabolic Health, Maternal-Infant Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 26 Feb 2024 (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 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.
Detailed description
Using this data, the investigators will address the following Specific Aims:
Specific Aim 1: To evaluate the effectiveness of MOMI PODS versus EUC in mitigating cardiometabolic and mental health risk across the PP year. Hypotheses: MOMI PODS (vs. EUC) recipients will show better cardiometabolic and mental health (Primary Outcomes: higher Life's Essential 8 scores, fewer depressive and anxiety symptoms, Secondary Outcomes: fewer emergency visits and hospital readmissions).
Specific Aim 2: To identify the biopsychosocial mechanisms through which MOMI PODS affects PP cardiometabolic and mental health at the individual patient level. Hypotheses: MOMI PODS (vs. EUC) recipients will report better patient-provider relationships and less psychosocial stress and show better stress-responsive endocrine and immune profiles, which will be critical drivers of cardiometabolic and mental health.
Specific Aim 3: To determine if MOMI PODS promosed longitudinal delivery of evidence-based PP care and identify strategies to improve implementation and service outcomes. Hypotheses: MOMI PODS (vs. EUC) recipients will receive clinical and supportive care that is more adherent to evidence-based guidelines. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity and timeliness of clinical and supportive care across MOMI PODS sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MOMI PODSMOMI 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 comparator | 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria will include the presence of a pre-existing, community driven MOMI PODS referral and enrollment into the program, maternal history of a seizure disorder, medical record documentation or self-report of a major complication of the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot. Exclusion criteria will also include the presence of a major genetic disorder among the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to trisomy 13, or trisomy 18 (trisomy 21 is not an exclusion criteria).
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 |
|---|---|---|
| MOMI PODSMOMI 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. | Behavioural | Intervention |
| 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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).
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 14 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMI PODS in people with Postpartum Depression and Postpartum Anxiety, run by Ohio State University 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 1 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 14 May 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 Shannon L. Gillespie, PhD, RN (6142924589, gillespie.175@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Life's Essential 8 (LE8) Composite Score (time frame: Baseline (T1) to 6 months postpartum (T2)). The study lists 9 primary outcomes in all. 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 14 May 2026.