Social Media and Risk Reduction Teaching-Enhanced Reach

Breastfeeding Clinical Trial

— SMARTER  

Official title:

Improving Care Giver Adherence to Recommended Infant Care Practices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387552
• Other study ID #: H-39495
• Secondary ID: R01HD072815-06A1
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: Boston University
• Contact: Fiona Rice, MPH
• Phone: 617-206-6149
• Email: fionar[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: October 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• SIDS
• SUID

Intervention

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.
• Prenatal Breastfeeding Mobile Health (mHealth) Messaging
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
• 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.
• Postnatal Breastfeeding Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.

Locations

Country	Name	City	State
United States	Boston University Medical Campus	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Boston University	Boston Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Kentucky, University of Virginia, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between 2 and 6 months
Primary	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.	Between 2 and 6 months
Primary	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
Primary	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
Primary	Breast milk 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.	Between 2 and 6 months
Secondary	Age in weeks when Infant stopped supine sleep position	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.	Weekly until the infant is 26 weeks of age.
Secondary	Age in weeks when infant stopped room sharing without bed sharing	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.	Weekly until the infant is 26 weeks of age.
Secondary	Age in weeks when infant starts using soft bedding	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.	Weekly until the infant is 26 weeks of age.
Secondary	Age in weeks when infant starts to use a pacifier	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.	Weekly until the infant is 26 weeks of age.
Secondary	Age in weeks when infant breast milk feedings change	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.	Weekly until the infant is 26 weeks of age.