Breastfeeding, SIDS, SUID
Conditions
Keywords
Breastfeeding (BF), Sleep position, Safe Sleep (SS), Mobile Messaging, Social Media, WIC
Brief summary
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).
Detailed description
The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and breastfeeding (BF) within a population of pregnant Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients. The study will randomize 2,000 pregnant women, when they reach 34 weeks gestation, to one of four mHealth prenatal/postnatal messaging combinations of safe sleep and breastfeeding practices.
Interventions
BEHAVIORALPrenatal Safe Sleep Mobile Health (mHealth) Messaging
Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
BEHAVIORALPrenatal Breastfeeding Mobile Health (mHealth) Messaging
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
BEHAVIORALPostnatal Safe Sleep Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
BEHAVIORALPostnatal Breastfeeding Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Sponsors
Boston University
University of Virginia
Washington University School of Medicine
Boston Medical Center
University of Kentucky
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
The study will utilize a two-stage randomization approach in which pregnant women are randomly assigned to one of the two prenatal interventions (infant sleep practices messaging vs. infant feeding messaging) and then, at the time of birth ascertainment, randomization to one of two postnatal interventions (infant sleep practice messaging vs. infant feeding messaging). This will result in a classic 2 x 2 design where approximately 25% of participants will have been assigned to each of the four possible combinations of interventions (1 - prenatal sleep practices/ postnatal sleep practices; 2 - prenatal sleep practices/postnatal feeding practices; 3 - prenatal feeding practices/postnatal sleep practices; 4 - prenatal feeding practices/postnatal feeding practices).
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be client at a WIC center participating in study. * Must be pregnant and less than 34 weeks gestation * Must speak English or Spanish * Must live in the United States * Must have texting capabilities via mobile phone * Must plan to live in same household as infant after birth.
Exclusion criteria
* A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning. * Meets the definition of a minor according to applicable state law.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With no Soft Bedding Use in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess soft bedding placed in and around the infant (while sleeping) during the previous two weeks with categorical responses of Yes or No. |
| Number of Infants Usually Sleeping Supine in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other. |
| Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing. |
| Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed. |
| Number of Infants With Pacifier Use in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess the infant's pacifier use during the previous two weeks with categorical responses of Yes or No. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks |
| Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing. |
| Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks | Between 2 and 6 months following postnatal randomization, on average 67.7 days | An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael J Corwin, MD
Boston University School of Public Health, Dept of Pediatrics, BUSM
Participant flow
Recruitment details
303 of the 2093 enrolled were not randomized prenatally due to: participant choice (165), study ended (56), pregnancy loss (26), delivery \<34 wks (17), contraindications (17), not pregnant (15), other (7). Infants were not considered to be enrolled.
Pre-assignment details
There was a 2- step randomization process- prenatally to 2 arms (n=1790, 897 randomized to prenatal safe sleep/SS and 893 randomized to prenatal breastfeeding/BF) and postnatally to 4 arms (n=1775). 15 of the 1790 randomized prenatally were not randomized postnatally- 7 of the 897 randomized to safe sleep/SS due to: participant choice (6), pregnancy loss (1), and 8 of the 893 randomized to breastfeeding/BF due to: participant choice (6), changed contact (1), pregnancy loss (1).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 24-29 years | 117 Participants |
| Age, Customized <24 years | 284 Participants |
| Age, Customized 30-34 years | 375 Participants |
| Age, Customized 35+ years | 281 Participants |
| Race/Ethnicity, Customized Hispanic, any race | 96 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 323 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Other | 28 Participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 165 Participants |
| Race/Ethnicity, Customized Unknown | 6 Participants |
| Region of Enrollment United States | 350 participants |
| Sex: Female, Male Female | 1383 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 346 | 0 / 350 | 0 / 338 | 0 / 349 |
| other Total, other adverse events | 0 / 346 | 0 / 350 | 0 / 338 | 0 / 349 |
| serious Total, serious adverse events | 0 / 346 | 0 / 350 | 0 / 338 | 0 / 349 |
Outcome results
None listed