Support Via Online Social Networks to Promote Safe Infant Care Practices

NCT05767658 — Not applicable, Recruiting, 3000 participants, University of Virginia

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

RegistryNCT05767658, acronym SUPERSONIC
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, factorial, masking: single, prevention
Enrollment3000 (Estimated)
SponsorUniversity of Virginia (Other); collaborators: Boston University, Washington University School of Medicine, Boston Medical Center, University of Kentucky, National Institute on Minority Health and Health Disparities (NIMHD)
ConditionsBreastfeeding, Infant Death, Sudden Infant Death Syndrome Without Mention of Autopsy
InterventionsSafe Sleep, Breastfeeding, Early Brain Development and Parent-Child Relationships (Behavioral)
Datesstart 2024-03-01, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2023-03-14, last updated 2026-01-12
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Breastfeeding All trials for Infant Death All trials of Safe Sleep All trials of Breastfeeding

-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); 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.

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+Arms and interventions

ArmTypeInterventionsDescription
Safe SleepExperimentalBehavioral: Safe SleepParticipants 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
BreastfeedingExperimentalBehavioral: BreastfeedingParticipants 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
Safe Sleep and BreastfeedingExperimentalBehavioral: Safe Sleep; Behavioral: BreastfeedingParticipants 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
Early Brain Development and Parent -Child RelationshipsActive comparatorBehavioral: Early Brain Development and Parent-Child RelationshipsParticipants 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.
  • Safe Sleep (Behavioral): 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.
  • Breastfeeding (Behavioral): 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.
  • Early Brain Development and Parent-Child Relationships (Behavioral): 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.

+Outcome measures

Primary outcomes

  • Exclusive infant supine sleep position in the previous two weeks [Between 2 and 6 months]: 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.
  • Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks [Between 2 and 6 months]: 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.
  • Soft bedding use in the previous two weeks [Between 2 and 6 months]: 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.
  • Breastmilk feeding in the previous two weeks [Between 2 and 6 months]: 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.

Secondary outcomes

  • Usual infant sleep position in the previous two weeks [Between 2 and 6 months]: 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.
  • . Usual infant sleep location in the previous two weeks [Between 2 and 6 months]: 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.
  • Pacifier use in the previous two weeks [Between 2 and 6 months]: 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.

+Eligibility

Sex: Female

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.

+Locations (1)

FacilityCityCountryStatus
Boston University Medical CampusBoston, MassachusettsUnited StatesRecruiting

+Publications

  • Results publication: Carlin RF, Parker MG, Kellams AL, Hauck FR, Kerr S, Cornwell BT, Kiviniemi MT, Geller N, Boguszewski KE, Corwin MJ, Colson ER, Moon RY. Delivering safe sleep and breastfeeding education to pregnant and new mothers through private Facebook groups: study protocol for a 4-armed randomized controlled trial. BMC Pediatr. 2026 Apr 22;26(1):528. doi: 10.1186/s12887-026-06900-9. PMID 42021196

+Investigators

+Funding

NIH grants: R01MD007702