N/A
N=1,600
Social Media And Risk-reduction Training for Infant Care Practices (SMART)
Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT01713868 ↗Enrolled (actual)
1,600
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Adherence With Recommended Supine Sleep Position — 230; 294; 294; 243 Participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Safe Sleep Nursery Education (Behavioral); Breastfeeding Nursery Education (Behavioral); Breastfeeding Mobile Health Messaging (Behavioral); Safe Sleep Mobile Health Messaging (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Virginia
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence With Recommended Supine Sleep Position |
230; 294; 294; 243; 71; 39 | 0.03 sig |
| PRIMARY Adherence With Recommended Roomsharing Without Bed Sharing |
218; 262; 269; 205; 75; 66 | <0.001 sig |
| PRIMARY Adherence With Recommended Pacifier Use |
193; 226; 240; 174; 97; 100 | <0.001 sig |
| PRIMARY Adherence With Recommended Avoiding Use of Soft Bedding |
204; 259; 262; 202; 96; 74 | <0.001 sig |
| SECONDARY Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep |
313; 491; 295; 164 | — |
| SECONDARY Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing. |
306; 442; 302; 213 | — |
| SECONDARY Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep |
332; 466; 276; 189 | — |
| SECONDARY Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing. |
297; 350; 311; 305 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01713868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.