An interventional study of Safe Sleep Nursery Education and Breastfeeding Nursery Education in Risk Reduction, sponsored by University of Virginia. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by University of Virginia · Not applicable, Interventional, and Prevention
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.
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Exclusion Criteria:
Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
Behavioral: Safe Sleep Nursery Education · Behavioral: Breastfeeding Mobile Health Messaging
Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
Behavioral: Breastfeeding Nursery Education · Behavioral: Safe Sleep Mobile Health Messaging
Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
Behavioral: Safe Sleep Nursery Education · Behavioral: Safe Sleep Mobile Health Messaging
Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
Behavioral: Breastfeeding Nursery Education · Behavioral: Breastfeeding Mobile Health Messaging
Nursery-based program for safe sleep
Nursery-based program to promote breastfeeding
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
Adherence With Recommended Supine Sleep Position
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.
Time frame: 6 months
Adherence With Recommended Roomsharing Without Bed Sharing
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.
Time frame: 6 months
Adherence With Recommended Pacifier Use
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.
Time frame: 6 months
Adherence With Recommended Avoiding Use of Soft Bedding
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.
Time frame: 6 months
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
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).
Time frame: 6 months
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
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).
Time frame: 6 months
Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
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.
Time frame: 6 months
Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
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
Time frame: 6 months
| Milestone | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth |
|---|---|---|---|---|
| Started | 400 | 400 | 400 | 400 |
| Completed | 303 | 335 | 320 | 305 |
| Not completed | 97 | 65 | 80 | 95 |
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.
| Participants | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth |
|---|---|---|---|---|
| Usual supine sleep position | 230 | 294 | 294 | 243 |
| Usual nonsupine position | 71 | 39 | 25 | 60 |
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.
| Participants | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth |
|---|---|---|---|---|
| Roomsharing without bedsharing | 218 | 262 | 269 | 205 |
| Not roomsharing without bedsharing | 75 | 66 | 44 | 86 |
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.
| Participants | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth |
|---|---|---|---|---|
| Usual pacifier use | 193 | 226 | 240 | 174 |
| Usual no pacifier use | 97 | 100 | 75 | 117 |
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.
| Participants | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth |
|---|---|---|---|---|
| No soft bedding use | 204 | 259 | 262 | 202 |
| Soft bedding use | 96 | 74 | 58 | 97 |
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).
| Participants | Control | mHealth Safe Sleep |
|---|---|---|
| # reporting positive attitudes re supine sleep | 313 | 491 |
| # reporting nonpositive attitudes re supine sleep | 295 | 164 |
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).
| Participants | Control | mHealth Safe Sleep |
|---|---|---|
| Positive attitude re: roomsharing w/o bedsharing | 306 | 442 |
| Nonpositive attitude re roomsharing w/o bedsharing | 302 | 213 |
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.
| Participants | Control | mHealth Safe Sleep |
|---|---|---|
| Positive social norms re supine sleep | 332 | 466 |
| Nonpositive social norms re supine sleep | 276 | 189 |
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
| Participants | Control | mHealth Safe Sleep |
|---|---|---|
| Positive social norms re roomsharing w/o bedsharin | 297 | 350 |
| Nonpositive norms re roomsharing w/o bedsharing | 311 | 305 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safe Sleep Edu and Breastfeeding mHealth | 0/400 (0%) | 0/400 (0%) | 0/400 (0%) |
| Breastfeeding Edu and Safe Sleep mHealth | 0/400 (0%) | 0/400 (0%) | 0/400 (0%) |
| Safe Sleep Edu and Safe Sleep mHealth | 0/400 (0%) | 0/400 (0%) | 0/400 (0%) |
| Breastfeed Edu and Breastfeed mHealth | 0/400 (0%) | 0/400 (0%) | 0/400 (0%) |
| Age, Categorical(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| <=18 years | 32 | 14 | 42 | 21 | 109 |
| Between 18 and 65 years | 368 | 386 | 358 | 379 | 1491 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Mean | 27.0 ± 5.9 | 29.3 ± 5.8 | 27.1 ± 5.9 | 27.6 ± 5.7 | 27.9 ± 5.6 |
| Sex: Female, Male(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Female | 303 | 335 | 320 | 305 | 1263 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 128 | 121 | 144 | 127 | 520 |
| Not Hispanic or Latino | 272 | 279 | 256 | 273 | 1080 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 12 | 26 | 6 | 20 | 64 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 173 | 101 | 95 | 133 | 502 |
| White | 112 | 205 | 187 | 141 | 645 |
| More than one race | 20 | 11 | 7 | 8 | 46 |
| Unknown or Not Reported | 83 | 57 | 105 | 98 | 343 |
| Maternal educational level(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Less than high school | 36 | 11 | 31 | 10 | 88 |
| High school or GED | 84 | 63 | 77 | 88 | 312 |
| Some college | 102 | 114 | 118 | 104 | 438 |
| College or more | 80 | 147 | 92 | 101 | 420 |
| Unknown | 1 | 0 | 2 | 2 | 5 |
| Household income(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Less than $20,000 | 49 | 30 | 55 | 47 | 181 |
| $20,000-49.999 | 59 | 62 | 56 | 62 | 239 |
| $50,000 or more | 81 | 175 | 91 | 88 | 435 |
| Unknown | 114 | 68 | 118 | 108 | 408 |
| Maternal marital status(Participants) | Safe Sleep Edu and Breastfeeding mHealth | Breastfeeding Edu and Safe Sleep mHealth | Safe Sleep Edu and Safe Sleep mHealth | Breastfeed Edu and Breastfeed mHealth | Total |
|---|---|---|---|---|---|
| Married | 127 | 203 | 147 | 163 | 640 |
| Never married | 158 | 111 | 151 | 132 | 552 |
| Divorced, separated, or widowed | 14 | 20 | 14 | 8 | 56 |
| Unknown | 4 | 1 | 8 | 2 | 15 |
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Plan to share: No
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