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

NCT07213284 | Not Yet Recruiting DMC

• 2 other identifiers: 00011005U54HD113291
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Outcomes; Pregnancy; Pregnancy, Complications

Keywords

Pregnancy; App; Behavioral Intervention; Web-based Application; Postpartum

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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 at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.

Study Arms (2)

MI MOM

EXPERIMENTAL

Participants receive app content and text messages with information designed to improve pregnancy outcomes.

Behavioral: MI MOM App

Treatment as Usual

NO INTERVENTION

Data collection for study outcomes only

Interventions

MI MOM App BEHAVIORAL

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.

MI MOM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant at 20 weeks gestation or less
• years of age or older
• Access to smartphone with text messaging and internet access
• Speaks English
• Enrolled in Medicaid for health insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (2)

• 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.

  PMID: 41423300 DERIVED

• Kelpin 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.

  PMID: 41282939 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pregnancy Complications; Alzheimer Disease

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Steven J Ondersma, PhD

CONTACT

313-444-9797; onders12@msu.edu

Claire E Margerison, PhD

CONTACT

517-353-8623; margeris@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcomes will be vital record and Medicaid claims data collected independent of this trial, and direct self-report via online survey software.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor- Tenure System

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: October 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Following NICHD data and specimen hub standards.
• Access Criteria: Following NICHD data and specimen hub standards.