CClinicalTrials.gg
RecruitingNCT05767658SUPERSONICUpdated Jan 12, 2026

Support Via Online Social Networks to Promote Safe Infant Care Practices

An interventional study of Safe Sleep and Breastfeeding in Breastfeeding, Infant Death and Sudden Infant Death Syndrome Without Mention of Autopsy, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by University of Virginia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Randomized
Sex
Female
01

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); 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.

02

Conditions studied

  • Breastfeeding
  • Infant Death
  • Sudden Infant Death Syndrome Without Mention of Autopsy

Keywords

  • Safe Sleep
  • Breastfeeding
  • Social Media
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
3,000 participants (estimated)

Study arms

  • 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

  • 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

  • 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 · Behavioral: Breastfeeding

  • 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

Interventions

  • BehavioralSafe 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.

  • BehavioralBreastfeeding

    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.

  • BehavioralEarly 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Between 2 and 6 months

  2. 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.

    Time frame: Between 2 and 6 months

  3. 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

  4. 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

Secondary outcomes

  1. 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.

    Time frame: Between 2 and 6 months

  2. . 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.

    Time frame: Between 2 and 6 months

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Boston University Medical Campus
    Boston, Massachusetts 02118, United States
    Recruiting
07

References and documents

Publications

  • 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. PubMed 42021196 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05767658
Lead sponsor
University of Virginia
Collaborators
Boston University, Washington University School of Medicine, Boston Medical Center, University of Kentucky, National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Rachel Moon, MD (Professor, Department of Pediatrics, University of Virginia) — Principal investigator
First posted
Mar 14, 2023
Start date
Mar 1, 2024
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jan 12, 2026

Study contacts

Katherine Boguszewski, MA
Contact
Keb5un@uvahealth.org
434-243-9663
Rachel Y Moon, MD
principal investigator · University of Virginia School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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