PregnancyMI-MOM AppNCT07213284
Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial
A study testing MI MOM App in people with Pregnancy and Pregnancy, Complications, run by Michigan State University at 8 sites in United States.
Trial summary
The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Pregnancy, Complications, Pregnancy Outcomes
- What is being tested?
- MI MOM App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Jul 2026to 31 Dec 2031
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant at 20 weeks gestation or less
- 18 years of age or older
- Access to smartphone with text messaging and internet access
- Speaks English
- Enrolled in Medicaid for health insurance
Who cannot join
- Younger than 18 years old
- Not pregnant or pregnant with more than 20 weeks gestation
- No access to a smartphone with text messaging and internet access
- Not English speaking
- Not enrolled in Medicaid for health insurance
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Shiawasee Health Department
Corunna, Michigan, 48817
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
McLaren Flint OB-GYN
Flint, Michigan, 48532
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
Munson Gaylord OB-GYN
Gaylord, Michigan, 49735
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
Trinity Health OB-GYN
Grand Rapids, Michigan, 49503
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
MidMichigan OB-GYN
Midland, Michigan, 48640
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
Munson Prudenville OB-GYN
Prudenville, Michigan, 48651
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
MyMichigan Sault OB-GYN
Sault Ste. Marie, Michigan, 49783
Ondersma, 313-444-9797, onders12@msu.edu
- Recruiting
Grand Traverse Women's Clinic
Traverse City, Michigan, 49684
Ondersma, 313-444-9797, onders12@msu.edu
About this study
Official title: Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes
The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.
Read the detailed description
The researchers aim to use a site-randomized design to determine whether the Michigan Healthy Mom (MI MOM) app will improve pregnancy health when used by pregnant women, their supporters (partners, mothers, friends, etc.), and healthcare providers, vs treatment as usual. Specifically, the researchers will test:
- Whether use of the MI MOM app results in improvements to self-reported app targets (e.g., reducing provider bias, increasing treatment-seeking, service connection, early warning sign awareness, and improving mental health)
- Whether use of the MI MOM app improved overall pregnancy and postpartum health
- Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants
- Conditions
- Pregnancy, Pregnancy, Complications, Pregnancy Outcomes
- Being tested
- MI MOM App
- Keywords
- Pregnancy, App, Behavioral Intervention, Web-based Application, Postpartum
- Medical subject headings
- Pregnancy Complications, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI MOM AppBehavioural
Participants enrolled in the Michigan Healthy Moms (MI MOM) app will receive initial interactive app content followed by regular text messages with information related to pregnancy health, designed to increase patient awareness of warning signs, help them with self-advocacy, and otherwise improve health in pregnancy and postpartum. They will also have online live chat (text) access to a community healthcare worker who can assist them in enrolling in services to improve their health. They will also have the option of enrolling support persons (partners, family members, close friends, etc.) in the MI MOM app to receive similar information designed to help them support the pregnant participant. Providers at intervention sites will also receive information designed to improve their awareness of techniques for preventing maternal morbidity and mortality.
| Study group | Role | What they receive |
|---|---|---|
| MI MOM | Experimental | Participants receive app content and text messages with information designed to improve pregnancy outcomes. Receives: Behavioral: MI MOM App |
| Treatment as Usual | No intervention | Data collection for study outcomes only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pregnancy-associated morbidity through one year postpartum
Total pregnancy-associated non-severe and severe maternal morbidity through 1 year postpartum. Non-severe maternal morbidity will be indexed using ICD codes taken from Medicaid records, with conditions taken from World Health Organization-identified Maternal Morbidity conditions (e.g., anemia, hypertension, depression). Severe maternal morbidity will use ICD codes identified for the 21 severe maternal morbidity indicators developed by the CDC.
Measured: Start of pregnancy through 1 year postpartum
Pregnancy-Associated Mortality through one year postpartum
Total pregnancy-associated mortality through 1 year postpartum as measured using a preexisting linked dataset of Medicaid claims, deaths, birth records, and Evidence-Based Practice Center (EPC) program data.
Measured: Start of Pregnancy through 1 year postpartum
Composite Index, total number of maternal morbidity and mortality risk factors
A composite index evaluating multiple maternal morbidity and mortality behavioral risk factors including the Tobacco, Alcohol, Prescription medication, and other Substance use Tool for substance use (TAPS); the Humiliation, Afraid, Rape, Kick questionnaire for intimate partner violence (HARK); the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) for symptoms of depression and anxiety; patient understanding of early warning signs of pregnancy complications and appropriate responses; confidence in ability to communicate effectively with healthcare providers; help-seeking behaviors/service utilization, and prenatal care adherence. Total score on this composite index will be the number of risks on which the participant is positive at that assessment point. All risks will refer to the time since becoming pregnant (baseline) or since the last assessment point (follow-up observations) except for depression and anxiety, which refer to the past two weeks.
Measured: Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Jul 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Steven J. Ondersma, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213284
- Sponsor's protocol ID
- 00011005
- Other IDs
- U54HD113291
- Acronym
- MI-MOM App
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study data that does not reveal participant identity.
Publications
Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol. BMJ Open. 2025 Dec 21;15(12):e113340. doi: 10.1136/bmjopen-2025-113340.
PubMed 41423300Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. A study protocol for a site-randomized trial of a multi-level digital intervention to reduce maternal morbidity & mortality. medRxiv [Preprint]. 2025 Oct 31:2025.10.29.25339066. doi: 10.1101/2025.10.29.25339066.
PubMed 41282939
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT07213284
- Acronym / sponsor ID
- MI-MOM App / 00011005
- Conditions
- Pregnancy, Pregnancy, Complications, Pregnancy Outcomes
- Keywords
- Pregnancy, App, Behavioral Intervention, Web-based Application, Postpartum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Oct 2025 (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 purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.
Detailed description
The researchers aim to use a site-randomized design to determine whether the Michigan Healthy Mom (MI MOM) app will improve pregnancy health when used by pregnant women, their supporters (partners, mothers, friends, etc.), and healthcare providers, vs treatment as usual. Specifically, the researchers will test:
- Whether use of the MI MOM app results in improvements to self-reported app targets (e.g., reducing provider bias, increasing treatment-seeking, service connection, early warning sign awareness, and improving mental health)
- Whether use of the MI MOM app improved overall pregnancy and postpartum health
- Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI MOM | Experimental | Behavioral: MI MOM AppParticipants receive app content and text messages with information designed to improve pregnancy outcomes. |
| Treatment as Usual | No intervention | –Data collection for study outcomes only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant at 20 weeks gestation or less
- 18 years of age or older
- Access to smartphone with text messaging and internet access
- Speaks English
- Enrolled in Medicaid for health insurance
Key exclusion criteria (5 listed)
- Younger than 18 years old
- Not pregnant or pregnant with more than 20 weeks gestation
- No access to a smartphone with text messaging and internet access
- Not English speaking
- Not enrolled in Medicaid for health insurance
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 |
|---|---|---|
| MI MOM AppParticipants enrolled in the Michigan Healthy Moms (MI MOM) app will receive initial interactive app content followed by regular text messages with information related to pregnancy health, designed to increase patient awareness of warning signs, help them with self-advocacy, and otherwise improve health in pregnancy and postpartum. They will also have online live chat (text) access to a community healthcare worker who can assist them in enrolling in services to improve their health. They will also have the option of enrolling support persons (partners, family members, close friends, etc.) in the MI MOM app to receive similar information designed to help them support the pregnant participant. Providers at intervention sites will also receive information designed to improve their awareness of techniques for preventing maternal morbidity and mortality. | Behavioural | MI MOM |
Primary outcome
Total pregnancy-associated morbidity through one year postpartum
Time frame: Start of pregnancy through 1 year postpartum
Total pregnancy-associated non-severe and severe maternal morbidity through 1 year postpartum. Non-severe maternal morbidity will be indexed using ICD codes taken from Medicaid records, with conditions taken from World Health Organization-identified Maternal Morbidity conditions (e.g., anemia, hypertension, depression). Severe maternal morbidity will use ICD codes identified for the 21 severe maternal morbidity indicators developed by the CDC.
Pregnancy-Associated Mortality through one year postpartum
Time frame: Start of Pregnancy through 1 year postpartum
Total pregnancy-associated mortality through 1 year postpartum as measured using a preexisting linked dataset of Medicaid claims, deaths, birth records, and Evidence-Based Practice Center (EPC) program data.
Composite Index, total number of maternal morbidity and mortality risk factors
Time frame: Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.
A composite index evaluating multiple maternal morbidity and mortality behavioral risk factors including the Tobacco, Alcohol, Prescription medication, and other Substance use Tool for substance use (TAPS); the Humiliation, Afraid, Rape, Kick questionnaire for intimate partner violence (HARK); the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) for symptoms of depression and anxiety; patient understanding of early warning signs of pregnancy complications and appropriate responses; confidence in ability to communicate effectively with healthcare providers; help-seeking behaviors/service utilization, and prenatal care adherence. Total score on this composite index will be the number of risks on which the participant is positive at that assessment point. All risks will refer to the time since becoming pregnant (baseline) or since the last assessment point (follow-up observations) except for depression and anxiety, which refer to the past two weeks.
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 24 Jul 2026.
- Derived from this study: PubMed 41423300Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol. BMJ Open. 2025 Dec 21;15(12):e113340. doi: 10.1136/bmjopen-2025-113340.
- Derived from this study: PubMed 41282939Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. A study protocol for a site-randomized trial of a multi-level digital intervention to reduce maternal morbidity & mortality. medRxiv [Preprint]. 2025 Oct 31:2025.10.29.25339066. doi: 10.1101/2025.10.29.25339066.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All study data that does not reveal participant identity.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI MOM App in people with Pregnancy and Pregnancy, Complications, run by Michigan State University at 8 sites 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 5 inclusion and 5 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Steven J Ondersma, PhD (313-444-9797, onders12@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pregnancy-associated morbidity through one year postpartum (time frame: Start of pregnancy through 1 year postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07213284, which also lists 2 linked publications.
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 24 Jul 2026.