Social Media And Risk-reduction Training for Infant Care Practices (SMART)
SMART
1 other identifier
interventional
1,600
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedResults Posted
Study results publicly available
January 3, 2019
CompletedJanuary 11, 2019
January 1, 2019
1.6 years
October 19, 2012
November 14, 2018
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Adherence With Recommended Supine Sleep Position
Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
6 months
Adherence With Recommended Roomsharing Without Bed Sharing
Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
6 months
Adherence With Recommended Pacifier Use
Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
6 months
Adherence With Recommended Avoiding Use of Soft Bedding
Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
6 months
Secondary Outcomes (4)
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
6 months
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
6 months
Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
6 months
Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
6 months
Study Arms (4)
Safe Sleep Edu and Breastfeeding mHealth
OTHERParticipants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
Breastfeeding Edu and Safe Sleep mHealth
OTHERParticipants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
Safe Sleep Edu and Safe Sleep mHealth
OTHERParticipants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
Breastfeed Edu and Breastfeed mHealth
OTHERParticipants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
Interventions
Nursery-based program for safe sleep
Nursery-based program to promote breastfeeding
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
Eligibility Criteria
You may qualify if:
- \- mothers must live in the US, deliver a healthy infant in one of the study hospitals, plan to take her baby home with her, and be able to receive emails.
You may not qualify if:
- \- mothers who are not English speaking, whose infant is deceased, those not having custody of the infant, and those whose infants require hospitalization for more than 1 week, or have an ongoing medical problem requiring subspecialty care and mothers who are unable to receive email messages.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- Yale Universitycollaborator
- Boston Universitycollaborator
Related Publications (3)
Kellams A, Kerr SM, Moon RY, Hauck FR, Heeren T, Colson E, Parker MG, Rice F, Corwin MJ. The Impact of Breastfeeding and Safe Sleep Mobile Health Messaging on Breastfeeding and Bedsharing. Acad Pediatr. 2022 Aug;22(6):927-934. doi: 10.1016/j.acap.2022.01.016. Epub 2022 Feb 4.
PMID: 35124281DERIVEDMoon RY, Corwin MJ, Kerr S, Heeren T, Colson E, Kellams A, Geller NL, Drake E, Tanabe K, Hauck FR. Mediators of Improved Adherence to Infant Safe Sleep Using a Mobile Health Intervention. Pediatrics. 2019 May;143(5):e20182799. doi: 10.1542/peds.2018-2799.
PMID: 31015374DERIVEDMoon RY, Hauck FR, Colson ER, Kellams AL, Geller NL, Heeren T, Kerr SM, Drake EE, Tanabe K, McClain M, Corwin MJ. The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices: A Randomized Clinical Trial. JAMA. 2017 Jul 25;318(4):351-359. doi: 10.1001/jama.2017.8982.
PMID: 28742913DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There was a 21% loss to follow-up, not generalizable to non-English-speaking populations, not powered to assess adverse events, did not measure clinical outcomes (i.e., rates of sudden unexpected infant death), and the results were self-reported
Results Point of Contact
- Title
- Michael Corwin, MD
- Organization
- Boston University
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Corwin, MD
Boston University
- PRINCIPAL INVESTIGATOR
Eve R Colson, M.D.
Yale University
- PRINCIPAL INVESTIGATOR
Fern R Hauck, M.D., M.S.
University of Virginia
- PRINCIPAL INVESTIGATOR
Rachel Moon, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rachel Moon, M.D.
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 25, 2012
Study Start
March 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2017
Last Updated
January 11, 2019
Results First Posted
January 3, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share