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

This study is not yet open for participant recruitment.
Verified October 2012 by Children's Research Institute
Sponsor:
Collaborators:
Yale University
University of Virginia
Boston University
Information provided by (Responsible Party):
Rachel Moon, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01713868
First received: October 19, 2012
Last updated: October 23, 2012
Last verified: October 2012

October 19, 2012
October 23, 2012
September 2013
September 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01713868 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Social Media And Risk-reduction Training for Infant Care Practices (SMART)
Social Media And Risk-reduction Training for Infant Care Practices (SMART)

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.

FOA PAR-11-242 seeks research that will improve the design, implementation, and effectiveness of interventions to prevent Sudden Infant Death Syndrome (SIDS) and unintentional injury-related infant deaths associated with the sleep environment. The SMART (Social Media and Risk Reduction Training) Infant Care Practices proposal is a collaborative effort among researchers who collectively have generated much of the data on infant care practices that underlie the need for this FOA, and who have access to an already existing and operational infrastructure that permits performance of a large randomized clinical trial to study preventative interventions. This infrastructure was created for the NICHD-funded SAFE Infant Care Practices study, for which mothers are being recruited in 2011, 2012, and 2013 at a nationally-representative group of birth hospitals, with completion of infant care practice surveys at 2-5 months after birth. These hospitals, which will complete their participation in SAFE during 2013, are geographically and culturally diverse, will have had 3 years of baseline infant care practice data collected, and have a proven track record of successful recruitment. We will use our collective extensive experience 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. Both of the proposed intervention strategies, described below, were selected largely because they can be used in diverse populations and offer the potential to be rapidly disseminated nationwide.

Nursery Education: A nursery-based training program will be modeled after our successful pilot study and informed by our collective research on barriers to adopting safe sleep practices. We will use social marketing strategies to capture the attention of nursing staff and empower them to improve safe sleep practice modeling and messaging received by mothers and extended families during the post-partum hospital stay.

mHealth: We will use an innovative approach, using mobile messaging, that applies expertise in social marketing to provide multiple short culturally competent videos delivered via email from the end of the post-partum hospital stay through 2 months of age. This strategy will leverage the internet as a powerful tool to access health information, and mobile devices (e.g., cell phones), which have made internet access possible for many, particularly those who are younger, minority, and from lower socioeconomic and educational backgrounds. Using technology to deliver health-related information is likely to be a well-accepted and effective strategy, particularly among minority and low-income populations. Indeed, studies demonstrate that email may be an effective, inexpensive, and time-efficient strategy to transmit health information.

For each of the safe sleep practice interventions (Nursery Education and mHealth), we will develop control interventions in which the Nursery Education or mHealth approach is used to promote breastfeeding. We have chosen breastfeeding as the control intervention because it 1) is not expected to impact endpoints critical to the assessment of the safe sleep practice intervention, and 2) provides health promoting messages to control mothers.

In the SMART study, we propose a 4-arm RCT in which 16 hospitals completing participation in the SAFE study are randomly assigned to one of the following groups (with Safe Sleep Intervention and/or Breastfeeding Control): 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; and 4) Breastfeeding Nursery Education and Breastfeeding mHealth messaging. We are uniquely positioned to design, implement and test the effectiveness of these interventions in a methodologically rigorous way and propose the following specific aims: Primary Aim: To assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the breastfeeding controls.

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.

Secondary Aim: Assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches.

Hypothesis: Changes in variables within each of the domains of the Theory of Planned Behavior (Attitudes/Beliefs, Social Norms, Perceived Control) will be mediators of the effectiveness of safe sleep interventions.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Risk Reduction
  • Behavioral: Safe Sleep Nursery Education
    Nursery-based program for safe sleep
  • 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.
  • 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 Breastfeeding mHealth
    Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
    Interventions:
    • Behavioral: Safe Sleep Nursery Education
    • Behavioral: Breastfeeding Mobile Health Messaging
  • Breastfeeding Edu and Safe Sleep mHealth
    Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
    Interventions:
    • Behavioral: Breastfeeding Nursery Education
    • Behavioral: Safe Sleep Mobile Health Messaging
  • Safe Sleep Edu and Safe Sleep mHealth
    Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
    Interventions:
    • Behavioral: Safe Sleep Nursery Education
    • Behavioral: Safe Sleep Mobile Health Messaging
  • Breastfeed Edu and Breastfeed mHealth
    Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
    Interventions:
    • Behavioral: Breastfeeding Nursery Education
    • Behavioral: Breastfeeding Mobile Health Messaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1600
September 2016
September 2016   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
Yes
Contact: Brandi L Joyner, MSA 202-476-4913 bljoyner@childrensnational.org
Not Provided
 
NCT01713868
1RO1HD072815-01
Yes
Rachel Moon, Children's Research Institute
Children's Research Institute
  • Yale University
  • University of Virginia
  • Boston University
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
Children's Research Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP