BreastfeedingSUPERSONICNCT05767658
Support Via Online Social Networks to Promote Safe Infant Care Practices
A study testing Safe Sleep, Breastfeeding and Early Brain Development and Parent-Child Relationships in people with Breastfeeding and Infant Death, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Infant Death, Sudden Infant Death Syndrome Without Mention of Autopsy
- What is being tested?
- Safe Sleep, Breastfeeding and Early Brain Development and Parent-Child Relationships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University Medical Campus
Boston, Massachusetts, 02118
Katherine Boguszewski, MA, 617-206-6269, kbogusze@bu.edu
About this study
Official title: 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.
- Being tested
- Safe Sleep, Breastfeeding, Early Brain Development and Parent-Child Relationships
- Keywords
- Safe Sleep, Breastfeeding, Social Media
- Medical subject headings
- Breast Feeding, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe SleepBehavioural
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.
BreastfeedingBehavioural
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 RelationshipsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Safe Sleep | Experimental | 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 Receives: Behavioral: Safe Sleep |
| Breastfeeding | Experimental | 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 Receives: Behavioral: Breastfeeding |
| Safe Sleep and Breastfeeding | Experimental | 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 Receives: Behavioral: Safe Sleep; Behavioral: Breastfeeding |
| Early Brain Development and Parent -Child Relationships | Active comparator | 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. Receives: Behavioral: Early Brain Development and Parent-Child Relationships |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Between 2 and 6 months
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.
Measured: 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.
Measured: Between 2 and 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Between 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Mar 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Rachel Moon, MD, University of Virginia
- Investigators
- Rachel Y Moon, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767658
- Sponsor's protocol ID
- H-43455
- Other IDs
- 5R01MD007702-07
- Acronym
- SUPERSONIC
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality
- ClinicalTrials.gov ID
- NCT05767658
- Acronym / sponsor ID
- SUPERSONIC / H-43455
- Keywords
- Safe Sleep, Breastfeeding, Social Media
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Boston University, Washington University School of Medicine, Boston Medical Center, University of Kentucky, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safe Sleep | Experimental | Behavioral: 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 |
| Breastfeeding | Experimental | 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 breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents |
| Safe Sleep and Breastfeeding | Experimental | Behavioral: 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 Relationships | Active comparator | Behavioral: 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Safe Sleep, Safe Sleep and Breastfeeding |
| 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. | Behavioural | Breastfeeding, Safe Sleep and Breastfeeding |
| 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. | Behavioural | Early Brain Development and Parent -Child Relationships |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42021196Carlin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Y Moon, MD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Sleep, Breastfeeding and Early Brain Development and Parent-Child Relationships in people with Breastfeeding and Infant Death, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Boguszewski, MA (434-243-9663, Keb5un@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive infant supine sleep position in the previous two weeks (time frame: Between 2 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.