Social Media and Risk Reduction Teaching-Enhanced Reach

NCT04387552 | Completed Results DMC

• 2 other identifiers: H-39495R01HD072815-06A1
• Study Type: interventional
• Target: 2,093
• Locations: 1 country
• Sites: 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).

Conditions

Breastfeeding; SUID; SIDS

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Between 2 and 6 months following postnatal randomization, on average 67.7 days

Secondary Outcomes (3)

• Number of Infants Exclusively Sleeping Supine in 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

  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

  Between 2 and 6 months following postnatal randomization, on average 67.7 days

Study Arms (4)

Prenatal SS/Postnatal SS

EXPERIMENTAL

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

Prenatal SS/Postnatal BF

EXPERIMENTAL

Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages

Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging; Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Prenatal BF/Postnatal SS

EXPERIMENTAL

Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages

Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Prenatal BF/Postnatal BF

EXPERIMENTAL

Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages

Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Interventions

Prenatal Safe Sleep Mobile Health (mHealth) Messaging BEHAVIORAL

Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.

Prenatal SS/Postnatal BF; Prenatal SS/Postnatal SS

Prenatal Breastfeeding Mobile Health (mHealth) Messaging BEHAVIORAL

Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.

Prenatal BF/Postnatal BF; Prenatal BF/Postnatal SS

Postnatal Safe Sleep Mobile Health (mHealth) Messaging BEHAVIORAL

Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.

Prenatal BF/Postnatal SS; Prenatal SS/Postnatal SS

Postnatal Breastfeeding Mobile Health (mHealth) Messaging BEHAVIORAL

Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.

Prenatal BF/Postnatal BF; Prenatal SS/Postnatal BF

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boston University: lead
• University of Virginia: collaborator
• Washington University School of Medicine: collaborator
• Boston Medical Center: collaborator
• University of Kentucky: collaborator
• 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

Location

Related Publications (1)

• 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.

  PMID: 42490082 DERIVED

MeSH Terms

Conditions

Breast Feeding; Sudden Infant Death

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Michael J. Corwin, MD
• Organization: Boston University School of Public Health & Pediatrics, Chobanian & Avedisian BUSM

mjcorwin@bu.edu

(617) 734-6006

Study Officials

• Michael J Corwin, MD

  Boston University School of Public Health, Dept of Pediatrics, BUSM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

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: August 26, 2026
• Results First Posted: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)