Skip to main content
OpenTrials
Completed

NCT Number: NCT04387552

Social Media and Risk Reduction Teaching-Enhanced Reach

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breastfeeding Behavior Breast Feeding Death Death, Sudden Feeding Behavior Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms SIDS SUID Sudden Infant Death

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral

Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.

Prenatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral

Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.

Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral

Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.

Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral

Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.

Primary outcomes

  1. Number of Infants Usually Sleeping Supine in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

  2. Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

  3. Number of Infants With no Soft Bedding Use in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

  4. Number of Infants With Pacifier Use in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

  5. Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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 outcomes

  1. Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks

  2. Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

  3. Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks

    Time frame: Between 2 and 6 months following postnatal randomization, on average 67.7 days

    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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • 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

Registry information

Official study title

Improving Care Giver Adherence to Recommended Infant Care Practices

Acronym: SMARTER

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 14, 2020
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.