CompletedNCT04387552SMARTERUpdated Aug 26, 2026Results posted

Social Media and Risk Reduction Teaching-Enhanced Reach

An interventional study of Prenatal Safe Sleep Mobile Health (mHealth) Messaging and Prenatal Breastfeeding Mobile Health (mHealth) Messaging in Breastfeeding, SUID and SIDS, sponsored by Boston University. Completed at 1 site in United States. Open to female participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Boston University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 2,093
Allocation: Randomized
Ages: 14 Years and older
Sex: Female

Study 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).

Read the 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.

Conditions studied

Breastfeeding
SUID
SIDS

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Keywords

Breastfeeding (BF)
Sleep position
Safe Sleep (SS)
Mobile Messaging
Social Media
WIC

In context

Breast Feeding

262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.

This study's enrollment of 2,093 is above the median of 95 across 210 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Single (Participant)
Enrollment: 2,093 participants (actual)

Study arms

Experimental
Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging · Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging
Experimental
Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging · Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging
Experimental
Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging · Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging
Experimental
Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging · Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Interventions

BehavioralPrenatal Safe Sleep Mobile Health (mHealth) Messaging
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
BehavioralPrenatal Breastfeeding Mobile Health (mHealth) Messaging
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
BehavioralPostnatal Safe Sleep Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
BehavioralPostnatal Breastfeeding Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.

What researchers measure

Primary outcomes

Number of Infants Usually Sleeping Supine 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 supine (back), prone (stomach), side, and other.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Number of Infants With 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.
Time frame: 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
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.
Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

Secondary outcomes

Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks
Time frame: 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
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.
Time frame: 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
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.
Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

Results

Posted Aug 26, 2026

Participant flow

303 of the 2093 enrolled were not randomized prenatally due to: participant choice (165), study ended (56), pregnancy loss (26), delivery \<34 wks (17), contraindications (17), not pregnant (15), other (7). Infants were not considered to be enrolled.

Prenatal Randomization Into 2 Arms

Participant flow — Prenatal Randomization Into 2 Arms
Milestone	Safe Sleep/SS	Breastfeeding/BF
Started	897	893
Completed	890	885
Not completed	7	8
Withdrew: Withdrawal by subject	6	6
Withdrew: Pregnancy loss	1	1
Withdrew: Lost to follow-up	0	1

Postnatal Randomization Into 4 Arms

Participant flow — Postnatal Randomization Into 4 Arms
Milestone	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Started	440	450	438	447
Completed	346	350	338	349
Not completed	94	100	100	98
Withdrew: Lost to follow-up	89	91	91	89
Withdrew: Discontinued intervention	5	9	9	9

Outcome measures

PrimaryNumber of Infants Usually Sleeping Supine 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 supine (back), prone (stomach), side, and other.

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants Usually Sleeping Supine in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants Usually Sleeping Supine in the Previous Two Weeks	308	317	299	305

PrimaryNumber of Infants Usually Room Sharing Without Bedsharing 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.

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks	297	292	287	280

PrimaryNumber of Infants With no 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.

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants With no Soft Bedding Use in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants With no Soft Bedding Use in the Previous Two Weeks	284	274	251	260

PrimaryNumber of Infants With 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.

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants With Pacifier Use in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants With Pacifier Use in the Previous Two Weeks	249	260	240	255

PrimaryNumber of Infants With Any Breastmilk 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.

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks	234	222	212	223

SecondaryNumber of Infants Exclusively Sleeping Supine in the Previous Two Weeks

An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks

Time frame:: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Reported as:: Count of participants · Participants

Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks	254	240	220	212

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks	243	240	232	219

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks
Participants	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF
Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks	116	106	107	117

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Prenatal SS/Postnatal SS	0/346 (0%)	0/346 (0%)	0/346 (0%)
Prenatal SS/Postnatal BF	0/350 (0%)	0/350 (0%)	0/350 (0%)
Prenatal BF/Postnatal SS	0/338 (0%)	0/338 (0%)	0/338 (0%)
Prenatal BF/Postnatal BF	0/349 (0%)	0/349 (0%)	0/349 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF	Total
<24 years	69	77	72	66	284
24-29 years	112	113	101	117	443
30-34 years	94	98	97	86	375
35+ years	71	62	68	80	281

Sex: Female, Male
Sex: Female, Male(Participants)	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF	Total
Female	346	350	338	349	1383
Male	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF	Total
Hispanic, any race	96	74	78	77	325
Non-Hispanic, Black	83	76	78	86	323
Non-Hispanic, Other	28	28	22	31	109
Non-Hispanic, White	131	165	153	149	598
Unknown	8	7	7	6	28

Region of Enrollment
Region of Enrollment(participants)	Prenatal SS/Postnatal SS	Prenatal SS/Postnatal BF	Prenatal BF/Postnatal SS	Prenatal BF/Postnatal BF	Total
United States	346	350	338	349	1383

Study locations

1 site

Boston University Medical Campus
Boston, Massachusetts 02118, United States

References and documents

Publications

Moon RY, Colson ER, Hauck FR, Kellams AL, Parker MG, Kerr SM, Geller NL, Boguszewski KE, Bellamy SL, Kiviniemi MT, Corwin MJ. Safe Sleep Video Intervention via Text Messaging to Low-Income Families: The SMARTER Randomized Clinical Trial. JAMA. 2026 Jul 23:e269119. doi: 10.1001/jama.2026.9119. Online ahead of print. PubMed 42490082 ↗

Study documents

Protocol and statistical analysis plan · Nov 5, 2024
Informed consent form · Jan 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04387552
Lead sponsor: Boston University
Collaborators: University of Virginia, Washington University School of Medicine, Boston Medical Center, University of Kentucky, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: May 14, 2020
Start date: Jan 20, 2022
Primary completion: Jun 7, 2025
Completion: Jun 7, 2025
Results posted: Aug 26, 2026
Last update: Aug 26, 2026

Study contacts

Michael J Corwin, MD

principal investigator · Boston University School of Public Health, Dept of Pediatrics, BUSM

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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