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Recruiting

NCT Number: NCT05767658

Support Via Online Social Networks to Promote Safe Infant Care Practices

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.

Recruiting

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Death Feeding Behavior Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death Syndrome Without Mention of Autopsy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Katherine Boguszewski, MA

CONTACT

[email protected]

617-206-6269

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Exclusive infant supine sleep position in the previous two weeks

    Time frame: 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.

  2. Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks

    Time frame: 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.

  3. Soft bedding use in the previous two weeks

    Time frame: 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.

  4. Breastmilk feeding in the previous two weeks

    Time frame: 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

  1. Usual infant sleep position in the previous two weeks

    Time frame: 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.

  2. . Usual infant sleep location in the previous two weeks

    Time frame: 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.

  3. Pacifier use in the previous two weeks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Boguszewski, MA

CONTACT

[email protected]

434-243-9663

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Boston Medical Center
  • Boston University
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of Kentucky
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: SUPERSONIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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