Social Media and Risk Reduction Teaching-Enhanced Reach
- Conditions
- SUIDSIDSBreastfeeding
- Interventions
- Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) MessagingBehavioral: Prenatal Safe Sleep Mobile Health (mHealth) MessagingBehavioral: Postnatal Breastfeeding Mobile Health (mHealth) MessagingBehavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging
- Registration Number
- NCT04387552
- Lead Sponsor
- Boston University
- 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) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 2126
- Must be client at a WIC center participating in study.
- Must be pregnant and less than 34 weeks gestation
- Must speak English or Spanish
- Must live in the United States
- Must have texting capabilities via mobile phone
- Must plan to live in same household as infant after birth.
- A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning.
- Meets the definition of a minor according to applicable state law.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Prenatal BF/Postnatal SS Prenatal Breastfeeding Mobile Health (mHealth) Messaging Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages Prenatal SS/Postnatal BF Postnatal Breastfeeding Mobile Health (mHealth) Messaging Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages Prenatal SS/Postnatal SS Postnatal Safe Sleep Mobile Health (mHealth) Messaging Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages Prenatal SS/Postnatal BF Prenatal Safe Sleep Mobile Health (mHealth) Messaging Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages Prenatal BF/Postnatal SS Postnatal Safe Sleep Mobile Health (mHealth) Messaging Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages Prenatal BF/Postnatal BF Prenatal Breastfeeding Mobile Health (mHealth) Messaging Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages Prenatal BF/Postnatal BF Postnatal Breastfeeding Mobile Health (mHealth) Messaging Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages Prenatal SS/Postnatal SS Prenatal Safe Sleep Mobile Health (mHealth) Messaging Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
- Primary Outcome Measures
Name Time Method Usual infant sleep location in the previous two weeks 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.
Soft bedding use in the previous two weeks 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.
Usual infant sleep position in the previous two weeks 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.
Pacifier use in the previous two weeks Between 2 and 6 months 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.
Breast milk feeding in the previous two weeks 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.
- Secondary Outcome Measures
Name Time Method Age in weeks when infant stopped room sharing without bed sharing Weekly until the infant is 26 weeks of age. The infant's age in weeks when sleep location of room sharing without bed sharing stopped will be assessed by maternal response to weekly text messages about sleep location during the past week.
Age in weeks when infant starts using soft bedding Weekly until the infant is 26 weeks of age. The infant's age in weeks when soft bedding use starts will be assessed by maternal response to weekly text messages about type of bedding during the past week.
Age in weeks when infant breast milk feedings change Weekly until the infant is 26 weeks of age. The infant's age in weeks when breast feeding changed will be assessed by maternal response to weekly text messages about type of breast feeding categorized as either exclusive, partial or no breast milk during the past week.
Age in weeks when infant starts to use a pacifier Weekly until the infant is 26 weeks of age. The infant's age in weeks when pacifier use started will be assessed by maternal response to weekly text messages about pacifier use during the past week.
Age in weeks when Infant stopped supine sleep position Weekly until the infant is 26 weeks of age. The infant's age in weeks when supine sleep position is stopped will be assessed by maternal response to weekly text messages about sleep position during the past week.
Trial Locations
- Locations (1)
Boston University Medical Campus
🇺🇸Boston, Massachusetts, United States