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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01713868
Acronym
SMART
Enrollment
1600
Registered
2012-10-25
Start date
2015-03-31
Completion date
2017-10-31
Last updated
2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Reduction

Keywords

Breastfeeding, Safe Sleep, Messaging, Social Media

Brief summary

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.

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.

Interventions

BEHAVIORALSafe Sleep Nursery Education

Nursery-based program for safe sleep

BEHAVIORALBreastfeeding Nursery Education

Nursery-based program to promote breastfeeding

BEHAVIORALBreastfeeding Mobile Health Messaging

Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

BEHAVIORALSafe Sleep Mobile Health Messaging

Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Sponsors

Yale University
CollaboratorOTHER
Boston University
CollaboratorOTHER
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence With Recommended Avoiding Use of Soft Bedding6 monthsHypothesis: 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.
Adherence With Recommended Supine Sleep Position6 monthsHypothesis: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 Sharing6 monthsHypothesis: 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 Use6 monthsHypothesis: 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.

Secondary

MeasureTime frameDescription
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep6 monthsQuestions 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.6 monthsQuestions 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 Sleep6 monthsSocial 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.6 monthsSocial 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

Participant flow

Participants by arm

ArmCount
Safe Sleep Edu and Breastfeeding mHealth
Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
400
Breastfeeding Edu and Safe Sleep mHealth
Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
400
Safe Sleep Edu and Safe Sleep mHealth
Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
400
Breastfeed Edu and Breastfeed mHealth
Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
400
Total1,600

Baseline characteristics

CharacteristicSafe Sleep Edu and Breastfeeding mHealthBreastfeeding Edu and Safe Sleep mHealthSafe Sleep Edu and Safe Sleep mHealthBreastfeed Edu and Breastfeed mHealthTotal
Age, Categorical
<=18 years
32 Participants14 Participants42 Participants21 Participants109 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
368 Participants386 Participants358 Participants379 Participants1491 Participants
Age, Continuous27.0 years
STANDARD_DEVIATION 5.9
29.3 years
STANDARD_DEVIATION 5.8
27.1 years
STANDARD_DEVIATION 5.9
27.6 years
STANDARD_DEVIATION 5.7
27.9 years
STANDARD_DEVIATION 5.6
Ethnicity (NIH/OMB)
Hispanic or Latino
128 Participants121 Participants144 Participants127 Participants520 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
272 Participants279 Participants256 Participants273 Participants1080 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Household income
$20,000-49.999
59 Participants62 Participants56 Participants62 Participants239 Participants
Household income
$50,000 or more
81 Participants175 Participants91 Participants88 Participants435 Participants
Household income
Less than $20,000
49 Participants30 Participants55 Participants47 Participants181 Participants
Household income
Unknown
114 Participants68 Participants118 Participants108 Participants408 Participants
Maternal educational level
College or more
80 Participants147 Participants92 Participants101 Participants420 Participants
Maternal educational level
High school or GED
84 Participants63 Participants77 Participants88 Participants312 Participants
Maternal educational level
Less than high school
36 Participants11 Participants31 Participants10 Participants88 Participants
Maternal educational level
Some college
102 Participants114 Participants118 Participants104 Participants438 Participants
Maternal educational level
Unknown
1 Participants0 Participants2 Participants2 Participants5 Participants
Maternal marital status
Divorced, separated, or widowed
14 Participants20 Participants14 Participants8 Participants56 Participants
Maternal marital status
Married
127 Participants203 Participants147 Participants163 Participants640 Participants
Maternal marital status
Never married
158 Participants111 Participants151 Participants132 Participants552 Participants
Maternal marital status
Unknown
4 Participants1 Participants8 Participants2 Participants15 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants26 Participants6 Participants20 Participants64 Participants
Race (NIH/OMB)
Black or African American
173 Participants101 Participants95 Participants133 Participants502 Participants
Race (NIH/OMB)
More than one race
20 Participants11 Participants7 Participants8 Participants46 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
83 Participants57 Participants105 Participants98 Participants343 Participants
Race (NIH/OMB)
White
112 Participants205 Participants187 Participants141 Participants645 Participants
Sex: Female, Male
Female
303 Participants335 Participants320 Participants305 Participants1263 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 4000 / 4000 / 4000 / 400
other
Total, other adverse events
0 / 4000 / 4000 / 4000 / 400
serious
Total, serious adverse events
0 / 4000 / 4000 / 4000 / 400

Outcome results

Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Avoiding Use of Soft BeddingNo soft bedding use204 Participants
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Avoiding Use of Soft BeddingSoft bedding use96 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Avoiding Use of Soft BeddingSoft bedding use74 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Avoiding Use of Soft BeddingNo soft bedding use259 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Avoiding Use of Soft BeddingNo soft bedding use262 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Avoiding Use of Soft BeddingSoft bedding use58 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Avoiding Use of Soft BeddingNo soft bedding use202 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Avoiding Use of Soft BeddingSoft bedding use97 Participants
Comparison: Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.p-value: <0.001Regression, Logistic
Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Pacifier UseUsual pacifier use193 Participants
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Pacifier UseUsual no pacifier use97 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Pacifier UseUsual no pacifier use100 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Pacifier UseUsual pacifier use226 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Pacifier UseUsual pacifier use240 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Pacifier UseUsual no pacifier use75 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Pacifier UseUsual pacifier use174 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Pacifier UseUsual no pacifier use117 Participants
Comparison: Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.p-value: <0.001Regression, Logistic
Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Roomsharing Without Bed SharingRoomsharing without bedsharing218 Participants
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Roomsharing Without Bed SharingNot roomsharing without bedsharing75 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Roomsharing Without Bed SharingNot roomsharing without bedsharing66 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Roomsharing Without Bed SharingRoomsharing without bedsharing262 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Roomsharing Without Bed SharingRoomsharing without bedsharing269 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Roomsharing Without Bed SharingNot roomsharing without bedsharing44 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Roomsharing Without Bed SharingRoomsharing without bedsharing205 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Roomsharing Without Bed SharingNot roomsharing without bedsharing86 Participants
Comparison: Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.p-value: <0.001Regression, Logistic
Primary

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

Population: Results analyzed at 2+ months infant age.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Supine Sleep PositionUsual supine sleep position230 Participants
Safe Sleep Edu and Breastfeeding mHealthAdherence With Recommended Supine Sleep PositionUsual nonsupine position71 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Supine Sleep PositionUsual nonsupine position39 Participants
Breastfeeding Edu and Safe Sleep mHealthAdherence With Recommended Supine Sleep PositionUsual supine sleep position294 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Supine Sleep PositionUsual supine sleep position294 Participants
Safe Sleep Edu and Safe Sleep mHealthAdherence With Recommended Supine Sleep PositionUsual nonsupine position25 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Supine Sleep PositionUsual supine sleep position243 Participants
Breastfeed Edu and Breastfeed mHealthAdherence With Recommended Supine Sleep PositionUsual nonsupine position60 Participants
Comparison: Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.p-value: 0.03Regression, Logistic
Secondary

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

Population: All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.Positive attitude re: roomsharing w/o bedsharing306 Participants
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.Nonpositive attitude re roomsharing w/o bedsharing302 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.Positive attitude re: roomsharing w/o bedsharing442 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.Nonpositive attitude re roomsharing w/o bedsharing213 Participants
Secondary

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

Population: All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep# reporting positive attitudes re supine sleep313 Participants
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep# reporting nonpositive attitudes re supine sleep295 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep# reporting positive attitudes re supine sleep491 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep# reporting nonpositive attitudes re supine sleep164 Participants
Secondary

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

Population: All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.Positive social norms re roomsharing w/o bedsharin297 Participants
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.Nonpositive norms re roomsharing w/o bedsharing311 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.Positive social norms re roomsharing w/o bedsharin350 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.Nonpositive norms re roomsharing w/o bedsharing305 Participants
Secondary

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

Population: All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re Supine SleepPositive social norms re supine sleep332 Participants
Safe Sleep Edu and Breastfeeding mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re Supine SleepNonpositive social norms re supine sleep276 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re Supine SleepPositive social norms re supine sleep466 Participants
Breastfeeding Edu and Safe Sleep mHealthNumber of Participants Reporting Positive/Nonpositive Social Norms re Supine SleepNonpositive social norms re supine sleep189 Participants

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026