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

Primary Purpose

Sudden Infant Death Syndrome (SIDS), Sudden Unexplained Infant Death (SUID), Breastfeeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Safe Sleep
Breastfeeding
Safe Sleep and Breastfeeding
Early Brain Development and Parent-Child Relationships
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Infant Death Syndrome (SIDS) focused on measuring Safe Sleep, Breastfeeding, Social Media, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Must be enrolled (or in process of enrolling) at a participating WIC center Must be English speaking Must be pregnant and less than 30 weeks gestation Must live in the United States Must have daily 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 breastfeeding 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Safe Sleep

    Breastfeeding

    Safe Sleep and Breastfeeding

    Early Brain Development and Parent -Child Relationships

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2023
    Last Updated
    March 2, 2023
    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)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05767658
    Brief Title
    Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality
    Acronym
    SUPERSONIC
    Official Title
    Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the 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)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sudden Infant Death Syndrome (SIDS), Sudden Unexplained Infant Death (SUID), Breastfeeding
    Keywords
    Safe Sleep, Breastfeeding, Social Media, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    3000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Safe Sleep
    Arm Type
    Experimental
    Arm Title
    Breastfeeding
    Arm Type
    Experimental
    Arm Title
    Safe Sleep and Breastfeeding
    Arm Type
    Experimental
    Arm Title
    Early Brain Development and Parent -Child Relationships
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Safe Sleep
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Breastfeeding
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Safe Sleep and Breastfeeding
    Intervention Description
    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 (combined intervention) b) an online community and social network of other pregnant WIC clients and new parents.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Early Brain Development and Parent-Child Relationships
    Intervention Description
    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 Measure Information:
    Title
    Infant sleep position in the previous two weeks
    Description
    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
    Title
    Infant sleep location in the previous two weeks
    Description
    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
    Title
    Soft bedding use in the previous two weeks
    Description
    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
    Title
    Pacifier use in the previous two weeks
    Description
    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
    Title
    Breastmilk feeding in the previous two weeks
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be enrolled (or in process of enrolling) at a participating WIC center Must be English speaking Must be pregnant and less than 30 weeks gestation Must live in the United States Must have daily 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 breastfeeding 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicole Geller, MPH
    Phone
    617-206-6269
    Email
    nls@bu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rachel Y Moon, MD
    Organizational Affiliation
    University of Virginia School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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