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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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)

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713868

Contacts
Contact: Brandi L Joyner, MSA 202-476-4913 bljoyner@childrensnational.org

Sponsors and Collaborators
Children's Research Institute
Yale University
University of Virginia
Boston University
Investigators
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 July 28, 2014