Social Media And Risk-reduction Training for Infant Care Practices (SMART)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Risk Reduction |
Behavioral: Safe Sleep Nursery Education Behavioral: Breastfeeding Nursery Education Behavioral: Breastfeeding Mobile Health Messaging Behavioral: Safe Sleep Mobile Health Messaging |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Social Media And Risk-reduction Training for Infant Care Practices (SMART) |
- Adherence with recommended safe sleep practices (supine sleep position, not bed sharing, pacifier use, avoiding use of soft bedding) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Hypothesis:For each recommended safe sleep practice (supine sleep position, not bed sharing, pacifier use, avoiding use of soft bedding), 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.
- Mediating factors assessment [ Time Frame: 3 years ] [ Designated as safety issue: No ]The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices.
| Estimated Enrollment: | 1600 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Safe Sleep Edu and Breastfeeding mHealth
Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
|
Behavioral: Safe Sleep Nursery Education
Nursery-based program for safe sleep
Behavioral: Breastfeeding Mobile Health Messaging
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
|
|
Breastfeeding Edu and Safe Sleep mHealth
Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
|
Behavioral: Breastfeeding Nursery Education
Nursery-based program to promote breastfeeding
Behavioral: Safe Sleep Mobile Health Messaging
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
|
|
Safe Sleep Edu and Safe Sleep mHealth
Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
|
Behavioral: Safe Sleep Nursery Education
Nursery-based program for safe sleep
Behavioral: Safe Sleep Mobile Health Messaging
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
|
|
Breastfeed Edu and Breastfeed mHealth
Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
|
Behavioral: Breastfeeding Nursery Education
Nursery-based program to promote breastfeeding
Behavioral: Breastfeeding Mobile Health Messaging
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Brandi L Joyner, MSA | 202-476-4913 | bljoyner@childrensnational.org |
| 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 | Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Rachel Moon, Rachel Moon, M.D., Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01713868 History of Changes |
| Other Study ID Numbers: | 1RO1HD072815-01 |
| Study First Received: | October 19, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Research Institute:
|
Breastfeeding Safe Sleep Messaging Social Media |
ClinicalTrials.gov processed this record on May 22, 2013