Trial Outcomes & Findings for Social Media And Risk-reduction Training for Infant Care Practices (SMART) (NCT NCT01713868)
NCT ID: NCT01713868
Last Updated: 2019-01-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1600 participants
Primary outcome timeframe
6 months
Results posted on
2019-01-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
400
|
400
|
400
|
400
|
|
Overall Study
COMPLETED
|
303
|
335
|
320
|
305
|
|
Overall Study
NOT COMPLETED
|
97
|
65
|
80
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of participants with data to analyze differed from the number of participants recruited because of attrition.
Baseline characteristics by cohort
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=400 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=400 Participants
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.
|
Safe Sleep Edu and Safe Sleep mHealth
n=400 Participants
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.
|
Breastfeed Edu and Breastfeed mHealth
n=400 Participants
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.
|
Total
n=1600 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=400 Participants
|
14 Participants
n=400 Participants
|
42 Participants
n=400 Participants
|
21 Participants
n=400 Participants
|
109 Participants
n=1600 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
368 Participants
n=400 Participants
|
386 Participants
n=400 Participants
|
358 Participants
n=400 Participants
|
379 Participants
n=400 Participants
|
1491 Participants
n=1600 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=1600 Participants
|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 5.9 • n=400 Participants
|
29.3 years
STANDARD_DEVIATION 5.8 • n=400 Participants
|
27.1 years
STANDARD_DEVIATION 5.9 • n=400 Participants
|
27.6 years
STANDARD_DEVIATION 5.7 • n=400 Participants
|
27.9 years
STANDARD_DEVIATION 5.6 • n=1600 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=303 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
335 Participants
n=335 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
320 Participants
n=320 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
305 Participants
n=305 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
1263 Participants
n=1263 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
|
Sex: Female, Male
Male
|
0 Participants
n=303 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
0 Participants
n=335 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
0 Participants
n=320 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
0 Participants
n=305 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
0 Participants
n=1263 Participants • Number of participants with data to analyze differed from the number of participants recruited because of attrition.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
128 Participants
n=400 Participants
|
121 Participants
n=400 Participants
|
144 Participants
n=400 Participants
|
127 Participants
n=400 Participants
|
520 Participants
n=1600 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
272 Participants
n=400 Participants
|
279 Participants
n=400 Participants
|
256 Participants
n=400 Participants
|
273 Participants
n=400 Participants
|
1080 Participants
n=1600 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=400 Participants
|
26 Participants
n=400 Participants
|
6 Participants
n=400 Participants
|
20 Participants
n=400 Participants
|
64 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
Black or African American
|
173 Participants
n=400 Participants
|
101 Participants
n=400 Participants
|
95 Participants
n=400 Participants
|
133 Participants
n=400 Participants
|
502 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=400 Participants
|
205 Participants
n=400 Participants
|
187 Participants
n=400 Participants
|
141 Participants
n=400 Participants
|
645 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=400 Participants
|
11 Participants
n=400 Participants
|
7 Participants
n=400 Participants
|
8 Participants
n=400 Participants
|
46 Participants
n=1600 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
83 Participants
n=400 Participants
|
57 Participants
n=400 Participants
|
105 Participants
n=400 Participants
|
98 Participants
n=400 Participants
|
343 Participants
n=1600 Participants
|
|
Maternal educational level
Less than high school
|
36 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited.
|
11 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited.
|
31 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited.
|
10 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited.
|
88 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited.
|
|
Maternal educational level
High school or GED
|
84 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited.
|
63 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited.
|
77 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited.
|
88 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited.
|
312 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited.
|
|
Maternal educational level
Some college
|
102 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited.
|
114 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited.
|
118 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited.
|
104 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited.
|
438 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited.
|
|
Maternal educational level
College or more
|
80 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited.
|
147 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited.
|
92 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited.
|
101 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited.
|
420 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited.
|
|
Maternal educational level
Unknown
|
1 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited.
|
0 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited.
|
2 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited.
|
2 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited.
|
5 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited.
|
|
Household income
Less than $20,000
|
49 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
30 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
55 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
47 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
181 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Household income
$20,000-49.999
|
59 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
62 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
56 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
62 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
239 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Household income
$50,000 or more
|
81 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
175 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
91 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
88 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
435 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Household income
Unknown
|
114 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
68 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
118 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
108 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
408 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Maternal marital status
Married
|
127 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
203 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
147 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
163 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
640 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Maternal marital status
Never married
|
158 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
111 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
151 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
132 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
552 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Maternal marital status
Divorced, separated, or widowed
|
14 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
20 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
14 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
8 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
56 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
|
Maternal marital status
Unknown
|
4 Participants
n=303 Participants • Because of attrition, number analyzed is less than number recruited
|
1 Participants
n=335 Participants • Because of attrition, number analyzed is less than number recruited
|
8 Participants
n=320 Participants • Because of attrition, number analyzed is less than number recruited
|
2 Participants
n=305 Participants • Because of attrition, number analyzed is less than number recruited
|
15 Participants
n=1263 Participants • Because of attrition, number analyzed is less than number recruited
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Results analyzed at 2+ months infant age.
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.
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=301 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=333 Participants
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.
|
Safe Sleep Edu and Safe Sleep mHealth
n=319 Participants
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.
|
Breastfeed Edu and Breastfeed mHealth
n=303 Participants
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.
|
|---|---|---|---|---|
|
Adherence With Recommended Supine Sleep Position
Usual supine sleep position
|
230 Participants
|
294 Participants
|
294 Participants
|
243 Participants
|
|
Adherence With Recommended Supine Sleep Position
Usual nonsupine position
|
71 Participants
|
39 Participants
|
25 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=293 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=328 Participants
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.
|
Safe Sleep Edu and Safe Sleep mHealth
n=313 Participants
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.
|
Breastfeed Edu and Breastfeed mHealth
n=291 Participants
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.
|
|---|---|---|---|---|
|
Adherence With Recommended Roomsharing Without Bed Sharing
Roomsharing without bedsharing
|
218 Participants
|
262 Participants
|
269 Participants
|
205 Participants
|
|
Adherence With Recommended Roomsharing Without Bed Sharing
Not roomsharing without bedsharing
|
75 Participants
|
66 Participants
|
44 Participants
|
86 Participants
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=290 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=326 Participants
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.
|
Safe Sleep Edu and Safe Sleep mHealth
n=315 Participants
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.
|
Breastfeed Edu and Breastfeed mHealth
n=291 Participants
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.
|
|---|---|---|---|---|
|
Adherence With Recommended Pacifier Use
Usual no pacifier use
|
97 Participants
|
100 Participants
|
75 Participants
|
117 Participants
|
|
Adherence With Recommended Pacifier Use
Usual pacifier use
|
193 Participants
|
226 Participants
|
240 Participants
|
174 Participants
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=300 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=333 Participants
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.
|
Safe Sleep Edu and Safe Sleep mHealth
n=320 Participants
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.
|
Breastfeed Edu and Breastfeed mHealth
n=299 Participants
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.
|
|---|---|---|---|---|
|
Adherence With Recommended Avoiding Use of Soft Bedding
No soft bedding use
|
204 Participants
|
259 Participants
|
262 Participants
|
202 Participants
|
|
Adherence With Recommended Avoiding Use of Soft Bedding
Soft bedding use
|
96 Participants
|
74 Participants
|
58 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=608 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=655 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
# reporting positive attitudes re supine sleep
|
313 Participants
|
491 Participants
|
—
|
—
|
|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
# reporting nonpositive attitudes re supine sleep
|
295 Participants
|
164 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=608 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=655 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
Positive attitude re: roomsharing w/o bedsharing
|
306 Participants
|
442 Participants
|
—
|
—
|
|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
Nonpositive attitude re roomsharing w/o bedsharing
|
302 Participants
|
213 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=608 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=655 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
Positive social norms re supine sleep
|
332 Participants
|
466 Participants
|
—
|
—
|
|
Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
Nonpositive social norms re supine sleep
|
276 Participants
|
189 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
Safe Sleep Edu and Breastfeeding mHealth
n=608 Participants
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.
|
Breastfeeding Edu and Safe Sleep mHealth
n=655 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
Positive social norms re roomsharing w/o bedsharin
|
297 Participants
|
350 Participants
|
—
|
—
|
|
Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
Nonpositive norms re roomsharing w/o bedsharing
|
311 Participants
|
305 Participants
|
—
|
—
|
Adverse Events
Safe Sleep Edu and Breastfeeding mHealth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breastfeeding Edu and Safe Sleep mHealth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safe Sleep Edu and Safe Sleep mHealth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breastfeed Edu and Breastfeed mHealth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place