Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial

Not Applicable

Not yet recruiting

• Conditions: Pregnancy; Pregnancy, Complications; Pregnancy Outcomes

• Registration Number: NCT07213284
• Lead Sponsor: Michigan State University

Brief 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. 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:

1. 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)

2. Whether use of the MI MOM app improved overall pregnancy and postpartum health

3. Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants

Study Timeline

• Study First Submitted: 2025-08-14
• Status Verified: 2025-09
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-12-31
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total pregnancy-associated morbidity through one year postpartum	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	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	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.