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mHealth Messaging for New Mothers (SMARTER Trial)

N/A
Recruiting
Led By Michael J Corwin, MD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must speak English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 2 and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether sending text messages about safe sleep and breastfeeding can help new mothers follow AAP recommendations.

Who is the study for?
This trial is for pregnant women in the U.S. under 34 weeks gestation, planning to live with their infant post-birth, and who are clients at a participating WIC center. They must speak English or Spanish and have texting capabilities on their mobile phone. It's not for minors or those with prenatal diagnoses affecting breastfeeding/sleep positioning.
What is being tested?
The study tests if mHealth messages about safe sleep and breastfeeding sent directly to mothers' phones can increase adherence to safe sleep practices and improve breastfeeding rates. It involves sending educational text messages both before and after birth.
What are the potential side effects?
Since this trial involves educational messaging via mobile health technologies, there are no direct medical side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 2 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 2 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Breast milk feeding in the previous two weeks
Pacifier use in the previous two weeks
Soft bedding use in the previous two weeks
+2 more
Secondary study objectives
Age in weeks when Infant stopped supine sleep position
Age in weeks when infant breast milk feedings change
Age in weeks when infant starts to use a pacifier
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Prenatal SS/Postnatal SSExperimental Treatment2 Interventions
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Group II: Prenatal SS/Postnatal BFExperimental Treatment2 Interventions
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Group III: Prenatal BF/Postnatal SSExperimental Treatment2 Interventions
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Group IV: Prenatal BF/Postnatal BFExperimental Treatment2 Interventions
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,293,360 Total Patients Enrolled
Boston UniversityLead Sponsor
472 Previous Clinical Trials
9,985,333 Total Patients Enrolled
University of VirginiaOTHER
782 Previous Clinical Trials
1,313,202 Total Patients Enrolled

Media Library

Postnatal Breastfeeding Mobile Health (mHealth) Messaging Clinical Trial Eligibility Overview. Trial Name: NCT04387552 — N/A
Breastfeeding Research Study Groups: Prenatal SS/Postnatal SS, Prenatal BF/Postnatal SS, Prenatal BF/Postnatal BF, Prenatal SS/Postnatal BF
Breastfeeding Clinical Trial 2023: Postnatal Breastfeeding Mobile Health (mHealth) Messaging Highlights & Side Effects. Trial Name: NCT04387552 — N/A
Postnatal Breastfeeding Mobile Health (mHealth) Messaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04387552 — N/A
~139 spots leftby Feb 2025
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