Social Media and Risk Reduction Teaching-Enhanced Reach

NCT ID: NCT04387552

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2025-06-06

Brief Summary

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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

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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.

Conditions

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Breastfeeding SUID SIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Prenatal SS/Postnatal BF

Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages

Group Type EXPERIMENTAL

Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Prenatal BF/Postnatal SS

Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages

Group Type EXPERIMENTAL

Prenatal Breastfeeding Mobile Health (mHealth) Messaging

Intervention Type 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

Intervention Type BEHAVIORAL

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

Prenatal SS/Postnatal SS

Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages

Group Type EXPERIMENTAL

Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Prenatal BF/Postnatal BF

Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages

Group Type EXPERIMENTAL

Prenatal Breastfeeding Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Prenatal Breastfeeding Mobile Health (mHealth) Messaging

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Postnatal Breastfeeding Mobile Health (mHealth) Messaging

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Corwin, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University School of Public Health, Dept of Pediatrics, BUSM

Locations

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Boston University Medical Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD072815-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-39495

Identifier Type: -

Identifier Source: org_study_id

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