Social Media and Risk Reduction Teaching-Enhanced Reach (SMARTER)
August 3, 2026 updated by: Boston University
Improving Care Giver Adherence to Recommended Infant Care Practices
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex.
text messaging).
Study Overview
Status
Completed
Conditions
Detailed Description
The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and breastfeeding (BF) within a population of pregnant Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients.
The study will randomize 2,000 pregnant women, when they reach 34 weeks gestation, to one of four mHealth prenatal/postnatal messaging combinations of safe sleep and breastfeeding practices.
Study Type
Interventional
Enrollment (Actual)
2093
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston University Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must be client at a WIC center participating in study.
- Must be pregnant and less than 34 weeks gestation
- Must speak English or Spanish
- Must live in the United States
- Must have texting capabilities via mobile phone
- Must plan to live in same household as infant after birth.
Exclusion Criteria:
- A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning.
- Meets the definition of a minor according to applicable state law.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
|
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|
Experimental: Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
|
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
|
Experimental: Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
|
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
|
Experimental: Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
|
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Infants Usually Sleeping Supine in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants With no Soft Bedding Use in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess soft bedding placed in and around the infant (while sleeping) during the previous two weeks with categorical responses of Yes or No.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants With Pacifier Use in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess the infant's pacifier use during the previous two weeks with categorical responses of Yes or No.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
|
Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks
Time Frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.
|
Between 2 and 6 months following postnatal randomization, on average 67.7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael J Corwin, MD, Boston University School of Public Health, Dept of Pediatrics, BUSM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2022
Primary Completion (Actual)
June 7, 2025
Study Completion (Actual)
June 7, 2025
Study Registration Dates
First Submitted
May 10, 2020
First Submitted That Met QC Criteria
May 10, 2020
First Posted (Actual)
May 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-39495
- R01HD072815-06A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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