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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD072815-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| Washington University School of Medicine | OTHER |
| Boston Medical Center | OTHER |
| University of Kentucky |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal SS/Postnatal BF | Experimental | Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages |
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| Prenatal BF/Postnatal SS | Experimental | Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages |
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| Prenatal SS/Postnatal SS | Experimental | Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages |
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| Prenatal BF/Postnatal BF | Experimental | Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatal Safe Sleep Mobile Health (mHealth) Messaging | Behavioral | Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant sleep position in the previous two weeks | An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of back, stomach, side, and other. We will examine: A) Usual position; B) Exclusive use of supine position | Between 2 and 6 months |
| Infant sleep location in the previous two weeks | 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. We will examine: A) Usual location; B) Exclusive location of room sharing without bedsharing | Between 2 and 6 months |
| Any Soft bedding use in the previous two weeks | 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. | Between 2 and 6 months |
| Any Pacifier use in the previous two weeks | 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. | Between 2 and 6 months |
| Infant feeding in the previous two weeks | 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. We will examine: A) Any breast milk feeding; B) Exclusive breast milk feeding | Between 2 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any Initiation of breast milk feeding | The impact of the only the prenatal intervention on initiation of breast milk feeding obtained through maternal survey responses on the prenatal survey | Between 36 weeks gestational age and birth |
| Planned infant sleep position after birth of baby |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Corwin, MD | Boston University School of Public Health, Dept of Pediatrics, BUSM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Medical Campus | Boston | Massachusetts | 02118 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 3, 2026 | |
| Release | Jun 9, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 |
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| OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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| Prenatal Breastfeeding Mobile Health (mHealth) Messaging | Behavioral | Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby. |
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| Postnatal Safe Sleep Mobile Health (mHealth) Messaging | Behavioral | Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period. |
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| Postnatal Breastfeeding Mobile Health (mHealth) Messaging | Behavioral | Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period. |
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The impact of the only the prenatal intervention on planned infant sleep position after birth of baby obtained through maternal survey responses on the prenatal survey |
| Between 36 weeks gestational age and birth. |
| Planned infant sleep location after birth of baby | The impact of the only the prenatal intervention on planned infant sleep location after birth of baby obtained through maternal survey responses on the prenatal survey | Between 36 weeks gestational age and birth. |
| Planned breast milk feeding after birth of baby | The impact of the only the prenatal intervention on planned breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey | Between 36 weeks gestational age and birth. |
| Planned duration of breast milk feeding after birth of baby | An investigator-developed maternal prenatal survey will be used to assess planned duration of breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey | Between 36 weeks gestational age and birth |
| Days from postnatal randomization to first report of not exclusively in the supine sleep position | The number of days after postnatal randomization when supine sleep position is stopped will be assessed by maternal response to weekly text messages about sleep position during the past week. | Weekly until the infant is 26 weeks of age. |
| Days from postnatal randomization to first report of not exclusively room sharing without bed sharing | The number of days after postnatal randomization when sleep location of room sharing without bed sharing stopped will be assessed by maternal response to weekly text messages about sleep location during the past week. | Weekly until the infant is 26 weeks of age. |
| Days from postnatal randomization to first report of using any soft bedding | The number of days after postnatal randomization when soft bedding use starts will be assessed by maternal response to weekly text messages about type of bedding during the past week. | Weekly until the infant is 26 weeks of age. |
| Days from postnatal randomization to first report of not receiving exclusively Breast Milk feedings | The days from postnatal randomization when breast feeding changed will be assessed by maternal response to weekly text messages about type of breast feeding categorized as either exclusive, partial or no breast milk during the past week. | Weekly until the infant is 26 weeks of age. |
| Days from postnatal randomization to first report of not receiving any Breast Milk feedings | The number of days after postnatal randomization to first report of not receiving any Breast Milk feedings will be assessed by maternal response to weekly text messages about type of breast feeding categorized as or no breast milk during the past week. | Weekly until the infant is 26 weeks of age. |
| Reset | Jul 2, 2026 |
| Mar 10, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2025 | Mar 16, 2026 | ICF_003.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 3, 2026 | |||
| Jun 9, 2026 | Jul 2, 2026 | |||
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D066088 | Infant Death |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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