Support Via Online Social Networks to Promote Safe Infant Care Practices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Safe Sleep
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
3,000 Participants
are divided into 4 treatment groupsGroup A: Safe SleepExperimental treatment 1 intervention
Group B: BreastfeedingExperimental treatment 1 intervention
Group C: Safe Sleep and BreastfeedingExperimental treatment 2 interventions
Group D: Early Brain Development and Parent -Child RelationshipsActive comparator 1 intervention
Trial outcomes
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 months2
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 months3
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 months4
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 monthsSecondary 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 months2
. 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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Boston University
Collaborator
Washington University School of Medicine
Collaborator
Boston Medical Center
Collaborator
University of Kentucky
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov