Social Media and Risk Reduction Teaching-Enhanced Reach
SMARTER
Improving Care Giver Adherence to Recommended Infant Care Practices
2 other identifiers
interventional
2,126
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2025
CompletedApril 17, 2026
April 1, 2026
3.4 years
May 10, 2020
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Infant sleep position in the previous two weeks
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of back, stomach, side, and other. We will examine: A) Usual position; B) Exclusive use of supine position
Between 2 and 6 months
Infant sleep location in the previous two weeks
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. We will examine: A) Usual location; B) Exclusive location of room sharing without bedsharing
Between 2 and 6 months
Any Soft bedding use in the previous two weeks
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
Any Pacifier use in the previous two weeks
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
Infant feeding in the previous two weeks
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. We will examine: A) Any breast milk feeding; B) Exclusive breast milk feeding
Between 2 and 6 months
Secondary Outcomes (10)
Any Initiation of breast milk feeding
Between 36 weeks gestational age and birth
Planned infant sleep position after birth of baby
Between 36 weeks gestational age and birth.
Planned infant sleep location after birth of baby
Between 36 weeks gestational age and birth.
Planned breast milk feeding after birth of baby
Between 36 weeks gestational age and birth.
Planned duration of breast milk feeding after birth of baby
Between 36 weeks gestational age and birth
- +5 more secondary outcomes
Study Arms (4)
Prenatal SS/Postnatal BF
EXPERIMENTALPrenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal BF/Postnatal SS
EXPERIMENTALPrenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal SS/Postnatal SS
EXPERIMENTALPrenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal BF/Postnatal BF
EXPERIMENTALPrenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Interventions
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
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.
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- University of Virginiacollaborator
- Washington University School of Medicinecollaborator
- Boston Medical Centercollaborator
- University of Kentuckycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (1)
Boston University Medical Campus
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Corwin, MD
Boston University School of Public Health, Dept of Pediatrics, BUSM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 14, 2020
Study Start
January 20, 2022
Primary Completion
June 7, 2025
Study Completion
June 7, 2025
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share