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

Boston University

Status: Completed

Conditions: SIDS; SUID; Breastfeeding

Treatments: Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging; Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging; Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging; Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04387552

R01HD072815-06A1 (U.S. NIH Grant/Contract)

H-39495

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,126 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,126 participants in 4 patient groups

Prenatal SS/Postnatal BF

Experimental group

Description:

Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages

Treatment:

Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Prenatal BF/Postnatal SS

Experimental group

Description:

Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages

Treatment:

Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging

Prenatal SS/Postnatal SS

Experimental group

Description:

Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages

Treatment:

Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Prenatal BF/Postnatal BF

Experimental group

Description:

Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages

Treatment:

Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging