Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMichigan State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant at 20 weeks gestation or less
18 years of age or older
Access to smartphone with text messaging and internet access
Speaks English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MI MOM App
BehavioralParticipants 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: MI MOMExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Start of pregnancy through 1 year postpartum2
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.
Time frame
Start of Pregnancy through 1 year postpartum3
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.
Time frame
Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michigan State University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov