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Recruiting NCT05767658

Support Via Online Social Networks to Promote Safe Infant Care Practices

No phase Interventional Breastfeeding Infant Death Sudden Infant Death Syndrome Without Mention of Autopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safe Sleep, Breastfeeding, Early Brain Development and Parent-Child Relationships.
Who it may be relevant to
Registry conditions: Breastfeeding, Infant Death, Sudden Infant Death Syndrome Without Mention of Autopsy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Exclusive infant supine sleep position in the previous two weeks [Time frame: Between 2 and 6 months]
  • Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks [Time frame: Between 2 and 6 months]
  • Soft bedding use in the previous two weeks [Time frame: Between 2 and 6 months]
  • Breastmilk feeding in the previous two weeks [Time frame: Between 2 and 6 months]
Secondary outcome measures (3)
  • Usual infant sleep position in the previous two weeks [Time frame: Between 2 and 6 months]
  • . Usual infant sleep location in the previous two weeks [Time frame: Between 2 and 6 months]
  • Pacifier use in the previous two weeks [Time frame: Between 2 and 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Boston University Medical Campus — Boston

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. PMID 42021196

Identifiers

NCT: NCT05767658 · H-43455 · 5R01MD007702-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗