Support Via Online Social Networks to Promote Safe Infant Care Practices (SUPERSONIC)

Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality

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); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.

Study Overview

• Status: Recruiting
• Conditions: Infant Death; Breastfeeding; Sudden Infant Death Syndrome Without Mention of Autopsy
• Intervention / Treatment: Behavioral: Safe Sleep; Behavioral: Breastfeeding; Behavioral: Early Brain Development and Parent-Child Relationships

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Boguszewski, MA; Phone Number: 434-243-9663; Email: Keb5un@uvahealth.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston University Medical Campus
      • Contact: Katherine Boguszewski, MA; Phone Number: 617-206-6269; Email: kbogusze@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Currently enrolled in WIC, or it not, then have either Medicaid or no health insurance
• Must be English speaking
• Must be pregnant and less than 30 weeks gestation
• Must live in the United States
• Must have regular access to Facebook and short message service (SMS) texting (mobile phone)

Exclusion Criteria:

• Not planning to live in same home as infant after birth.
• Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to feeding any breastmilk or supine infant sleep positioning.
• Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
• Meets the definition of a minor according to applicable state law.
• Participants who consent to participation in the study, must complete the Agile Onboarding process before they reach 30+0 weeks gestation.
• Currently or previously received a TodaysBaby educational program (randomized to a TodaysBaby program through either the SMARTER, or SUPERSONIC study), either in their current or a previous pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe Sleep; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents	Behavioral: Safe Sleep; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents.
Experimental: Breastfeeding; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents	Behavioral: Breastfeeding; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents.
Experimental: Safe Sleep and Breastfeeding; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and breastfeeding, and b) an online community and social network of other pregnant WIC clients and new parents	Behavioral: Safe Sleep; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents.; Behavioral: Breastfeeding; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents.
Active Comparator: Early Brain Development and Parent -Child Relationships; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.	Behavioral: Early Brain Development and Parent-Child Relationships; Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Exclusive infant supine sleep position in the previous two weeks	An investigator-developed maternal survey will be used to assess infant's usual sleep position during the previous two weeks with categorical responses of back, stomach, side, and other, with the proportion of infants using exclusive supine sleep position as the primary outcome measure.	Between 2 and 6 months
Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks	An investigator-developed maternal survey will be used to assess the infant's usual 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, with the proportion of infants exclusively room sharing without bed sharing as the primary outcome measure.	Between 2 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usual infant sleep position in the previous two weeks	An investigator-developed maternal survey will be used to assess infant's usual sleep position during the previous two weeks with categorical responses of back, stomach, side, and other.	Between 2 and 6 months
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
. Usual infant sleep location in the previous two weeks	An investigator-developed maternal survey will be used to assess the infant's usual 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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Boston University; Washington University School of Medicine; National Institute on Minority Health and Health Disparities (NIMHD); Boston Medical Center; University of Kentucky
• Investigators: Principal Investigator: Rachel Y Moon, MD, University of Virginia School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breastfeeding; Social Media; Safe Sleep
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Infant Death; Breast Feeding; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Lactation
• Other Study ID Numbers: H-43455; 5R01MD007702-07 (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
• product manufactured in and exported from the U.S.: No