Social Media And Risk-reduction Training for Infant Care Practices (SMART) (SMART)
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ClinicalTrials.gov Identifier: NCT01713868 |
Recruitment Status :
Completed
First Posted : October 25, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 11, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Risk Reduction | Behavioral: Safe Sleep Nursery Education Behavioral: Breastfeeding Nursery Education Behavioral: Breastfeeding Mobile Health Messaging Behavioral: Safe Sleep Mobile Health Messaging | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1600 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Social Media And Risk-reduction Training for Infant Care Practices (SMART) |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | October 2017 |

Arm | Intervention/treatment |
---|---|
Safe Sleep Edu and Breastfeeding mHealth
Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
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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. |
- Adherence With Recommended Supine Sleep Position [ Time Frame: 6 months ]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.
- Adherence With Recommended Roomsharing Without Bed Sharing [ Time Frame: 6 months ]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.
- Adherence With Recommended Pacifier Use [ Time Frame: 6 months ]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.
- Adherence With Recommended Avoiding Use of Soft Bedding [ Time Frame: 6 months ]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.
- Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep [ Time Frame: 6 months ]Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).
- Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing. [ Time Frame: 6 months ]Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).
- Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep [ Time Frame: 6 months ]Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.
- Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing. [ Time Frame: 6 months ]Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713868
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 |
Responsible Party: | Rachel Moon, MD, Rachel Moon, M.D., University of Virginia |
ClinicalTrials.gov Identifier: | NCT01713868 |
Other Study ID Numbers: |
1R01HD072815-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 25, 2012 Key Record Dates |
Results First Posted: | January 3, 2019 |
Last Update Posted: | January 11, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Breastfeeding Safe Sleep Messaging Social Media |