CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,600 enrolled
Drug / intervention
Safe Sleep Nursery Education +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01713868
NCT01713868N/ACompleted

Social Media And Risk-reduction Training for Infant Care Practices (SMART)

University of Virginia·interventional·Posted Oct 25, 2012·Updated Jan 11, 2019

In Brief

A clinical study evaluating Safe Sleep Nursery Education, Breastfeeding Nursery Education, and 2 other interventions for Risk Reduction. Completed, enrolled 1,600 participants.

Detailed Summary

The goal of this proposal is to address serious and ongoing challenges related to adherence to public health recommendations known to reduce the risk of SIDS. Adherence has reached a plateau at an unacceptably low level both in the overall US population and especially in Black infants leading to a halt in the decline in infant mortality and a widening in the racial disparity in infant mortality. The current proposal is a collaborative effort that will capitalize on the extensive experience of the investigators in studying barriers to adherence to safe sleep practices to develop two complementary, culturally competent, intervention strategies and to test the effectiveness of each strategy as well as both strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the field; 2) leveraging of the currently operational infant care practices study infrastructure and hospitals; 3) use of two complementary interventions with the potential for synergistic impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to deliver messages; and 6) collaboration with community resources and expertise. The SMART study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group. The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the breastfeeding control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. With the successful completion of the SMART study, effectiveness data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRisk Reduction
Countries--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2012
Enrollment StartMar 1, 2015
Primary CompletionOct 1, 2016
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.7 years ago

Interventions

Safe Sleep Nursery Educationbehavioral

Nursery-based program for safe sleep

Breastfeeding Nursery Educationbehavioral

Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messagingbehavioral

Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Safe Sleep Mobile Health Messagingbehavioral

Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.