Social Media and Risk Reduction Teaching-Enhanced Reach (SMARTER)

Improving Care Giver Adherence to Recommended Infant Care Practices

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).

Study Overview

• Status: Completed
• Conditions: Breastfeeding; SUID; SIDS
• Intervention / Treatment: Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging; Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging; Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) 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 Type: Interventional
• Enrollment (Actual): 2126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prenatal SS/Postnatal BF; Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages	Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging; Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.; Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging; Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Experimental: Prenatal BF/Postnatal SS; Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages	Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.; Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging; Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
Experimental: Prenatal SS/Postnatal SS; Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages	Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging; Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.; Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging; Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
Experimental: Prenatal BF/Postnatal BF; Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages	Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging; Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.; Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant sleep position 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 back, stomach, side, and other. We will examine: A) Usual position; B) Exclusive use of supine position	Between 2 and 6 months
Infant sleep location 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. We will examine: A) Usual location; B) Exclusive location of room sharing without bedsharing	Between 2 and 6 months
Any 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.	Between 2 and 6 months
Any 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.	Between 2 and 6 months
Infant 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. We will examine: A) Any breast milk feeding; B) Exclusive breast milk feeding	Between 2 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Initiation of breast milk feeding	The impact of the only the prenatal intervention on initiation of breast milk feeding obtained through maternal survey responses on the prenatal survey	Between 36 weeks gestational age and birth
Planned infant sleep position after birth of baby	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	Between 36 weeks gestational age and birth.
Planned infant sleep location after birth of baby	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	Between 36 weeks gestational age and birth.
Planned breast milk feeding after birth of baby	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	Between 36 weeks gestational age and birth.
Planned duration of breast milk feeding after birth of baby	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	Between 36 weeks gestational age and birth
Days from postnatal randomization to first report of not exclusively in the supine sleep position	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.	Weekly until the infant is 26 weeks of age.
Days from postnatal randomization to first report of not exclusively room sharing without bed sharing	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.	Weekly until the infant is 26 weeks of age.
Days from postnatal randomization to first report of using any soft bedding	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.	Weekly until the infant is 26 weeks of age.
Days from postnatal randomization to first report of not receiving exclusively Breast Milk feedings	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.	Weekly until the infant is 26 weeks of age.
Days from postnatal randomization to first report of not receiving any Breast Milk feedings	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.	Weekly until the infant is 26 weeks of age.

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Washington University School of Medicine; Boston Medical Center; University of Virginia; University of Kentucky
• Investigators: Principal Investigator: Michael J Corwin, MD, Boston University School of Public Health, Dept of Pediatrics, BUSM

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): June 7, 2025
• Study Completion (Actual): June 7, 2025

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mobile Messaging; Social Media; Sleep position; Breastfeeding (BF); Safe Sleep (SS); WIC
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Death, Sudden; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Infant Death; Sudden Infant Death; Breast Feeding; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: H-39495; R01HD072815-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No