NCT07213284 · Michigan State University
Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial
(MI-MOM App)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
MI MOM App
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.
Primary outcome measures
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.
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
- 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
Exclusion criteria
- 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
Where
- Corunna, Michigan
- Flint, Michigan
- Gaylord, Michigan
- Grand Rapids, Michigan
- Midland, Michigan
- Prudenville, Michigan
- Sault Ste. Marie, Michigan
- Traverse City, Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Jul 24, 2026 · Source of record for eligibility and locations