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) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).
The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and breastfeeding (BF) within a population of pregnant Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients. The study will randomize 2,000 pregnant women, when they reach 34 weeks gestation, to one of four mHealth prenatal/postnatal messaging combinations of safe sleep and breastfeeding practices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,093
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
Boston University Medical Campus
Boston, Massachusetts, United States
Number of Infants Usually Sleeping Supine in the Previous Two Weeks
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other.
Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks
An investigator-developed maternal survey will be used to assess the infant's 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 following postnatal randomization, on average 67.7 days
Number of Infants With no 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 months following postnatal randomization, on average 67.7 days
Number of Infants With 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 months following postnatal randomization, on average 67.7 days
Number of Infants With Any 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 months following postnatal randomization, on average 67.7 days
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Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks
Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days
Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks
An investigator-developed maternal survey will be used to assess the infant's 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 following postnatal randomization, on average 67.7 days
Number of Infants With Exclusive 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 months following postnatal randomization, on average 67.7 days