Social Media and Risk Reduction Teaching-Enhanced Reach

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Improving Care Giver Adherence to Recommended Infant Care Practices

ClinicalTrials.gov ID

NCT04387552

Acronym / sponsor ID

SMARTER / H-39495

Conditions

Breastfeeding, SUID, SIDS

Keywords

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

Study type

Interventional

Recruitment status

Completed

Enrolment

2,093 participants (actual)

Lead sponsor

Boston UniversityUniversity, hospital or other

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)

Study start

20 Jan 2022 (actual)

Primary completion

7 Jun 2025 (actual)

Study completion

7 Jun 2025 (actual)

First posted

14 May 2020 (actual)

Results

Posted 26 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Sequential

Masking

Single blind (participant)

Number of arms

4

Model description

The study will utilize a two-stage randomization approach in which pregnant women are randomly assigned to one of the two prenatal interventions (infant sleep practices messaging vs. infant feeding messaging) and then, at the time of birth ascertainment, randomization to one of two postnatal interventions (infant sleep practice messaging vs. infant feeding messaging). This will result in a classic 2 x 2 design where approximately 25% of participants will have been assigned to each of the four possible combinations of interventions (1 - prenatal sleep practices/ postnatal sleep practices; 2 - prenatal sleep practices/postnatal feeding practices; 3 - prenatal feeding practices/postnatal sleep practices; 4 - prenatal feeding practices/postnatal feeding practices).

Who may qualify

Ages

14 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 42490082Moon 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.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.