Social Media and Risk Reduction Teaching-Enhanced Reach

Not Applicable

Completed

• Conditions: SUID; SIDS; Breastfeeding

• 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.

Study Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-14
• Study Start: 2022-01-20
• Primary Completion: 2025-06-06
• Study Completion: 2025-06-06
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2126

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Primary Outcome Measures

Name	Time	Method
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 sleep position during the previous two weeks with categorical responses of back, stomach, side, and other. We will examine: A) Usual position; B) Exclusive use of supine position
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 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. We will examine: A) Usual location; B) Exclusive location of room sharing without bedsharing
Any 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.
Any 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.
Infant 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. We will examine: A) Any breast milk feeding; B) Exclusive breast milk feeding

Secondary Outcome Measures

Name	Time	Method
Any Initiation of breast milk feeding	Between 36 weeks gestational age and birth	The impact of the only the prenatal intervention on initiation of breast milk feeding obtained through maternal survey responses on the prenatal survey
Planned infant sleep position after birth of baby	Between 36 weeks gestational age and birth.	The impact of the only the prenatal intervention on planned infant sleep position after birth of baby obtained through maternal survey responses on the prenatal survey
Planned infant sleep location after birth of baby	Between 36 weeks gestational age and birth.	The impact of the only the prenatal intervention on planned infant sleep location after birth of baby obtained through maternal survey responses on the prenatal survey
Planned breast milk feeding after birth of baby	Between 36 weeks gestational age and birth.	The impact of the only the prenatal intervention on planned breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey
Planned duration of breast milk feeding after birth of baby	Between 36 weeks gestational age and birth	An investigator-developed maternal prenatal survey will be used to assess planned duration of breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey
Days from postnatal randomization to first report of not exclusively in the supine sleep position	Weekly until the infant is 26 weeks of age.	The number of days after postnatal randomization when supine sleep position is stopped will be assessed by maternal response to weekly text messages about sleep position during the past week.
Days from postnatal randomization to first report of not exclusively room sharing without bed sharing	Weekly until the infant is 26 weeks of age.	The number of days after postnatal randomization 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.
Days from postnatal randomization to first report of using any soft bedding	Weekly until the infant is 26 weeks of age.	The number of days after postnatal randomization when soft bedding use starts will be assessed by maternal response to weekly text messages about type of bedding during the past week.
Days from postnatal randomization to first report of not receiving exclusively Breast Milk feedings	Weekly until the infant is 26 weeks of age.	The days from postnatal randomization 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.
Days from postnatal randomization to first report of not receiving any Breast Milk feedings	Weekly until the infant is 26 weeks of age.	The number of days after postnatal randomization to first report of not receiving any Breast Milk feedings will be assessed by maternal response to weekly text messages about type of breast feeding categorized as or no breast milk during the past week.

Trial Locations

Locations (1)

Boston University Medical Campus; 🇺🇸 Boston, Massachusetts, United States