Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MI MOM App.
- Who it may be relevant to
- Registry conditions: Pregnancy, Pregnancy, Complications, Pregnancy Outcomes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes
Overview
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
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 al
Primary outcome measures
- Total pregnancy-associated morbidity through one year postpartum [Time frame: Start of pregnancy through 1 year postpartum]
- Pregnancy-Associated Mortality through one year postpartum [Time frame: Start of Pregnancy through 1 year postpartum]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 8 centers
- Shiawasee Health Department — Corunna
- McLaren Flint OB-GYN — Flint
- Munson Gaylord OB-GYN — Gaylord
- Trinity Health OB-GYN — Grand Rapids
- MidMichigan OB-GYN — Midland
- Munson Prudenville OB-GYN — Prudenville
- MyMichigan Sault OB-GYN — Sault Ste. Marie
- Grand Traverse Women's Clinic — Traverse City
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. PMID 41423300
- 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
Identifiers
NCT: NCT07213284 · 00011005 · U54HD113291