Health BehaviorSIDSNCT01361880
Reduce African-American Infant Mortality
A study testing Reduce Infant Mortality in people with Health Behavior, run by University of Virginia at 1 site in United States.
Trial summary
The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Reduce Infant Mortality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The purpose of the study is to determine the impact of a new educational strategy on African American parents, all participants will be self identified as African American. Although male parents will be allowed to participate in the followup surveys, female parents will be the primary focus of this study.
Who cannot join
- Mothers under the age of 18 years will not be included in the study. Infants born with congenital anomalies that would prevent them from sleeping in the supine position or if the infant is born at less than 36 weeks gestation, requires hospitalization for more than 1 week, or has ongoing medical problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Randomized Messaging Trial to Reduce African-American Infant Mortality
The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment. African-American parents of newborn, healthy term infants will be randomized to receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to prevent infant suffocation.
Read the detailed description
A persistent, significant racial disparity exists in infant mortality rates attributable to Sudden Infant Death Syndrome (SIDS) and other types of sleep-related sudden unexpected infant death (SUID), such as suffocation and undetermined causes of death. SIDS and other sleep-related deaths account for ~4600 U.S. deaths annually.4 While the incidence of SIDS has declined, infant deaths from accidental suffocation and strangulation in bed have quadrupled.5 Additionally, racial disparities in SIDS and other sleep-related deaths have increased over the past decade, with African-American infants twice as likely to die as other infants.6, 7 Certain infant sleeping practices, such as prone (stomach) sleeping, use of soft bedding and soft sleep surfaces, and bedsharing, likely play a significant role, both in SIDS and SUID, and in the disparities seen therein. Elimination of health barriers and racial/ethnic disparities, and promoting healthy development, have been highlighted as MCHB research priorities; this application is directly responsive to both of these priorities.
In the current system, health care providers and public health messages, using the American Academy of Pediatrics (AAP) recommendations,8 stress the use of supine (back) positioning, avoidance of soft bedding, and room sharing without bedsharing as recommendations to reduce the risk of SIDS. However, our research suggests that African-Americans have problems with this message, as they have a low degree of self-efficacy with regards to SIDS risk reduction (i.e., they do not believe that their actions can make a difference in whether SIDS occurs) and are suspicious of the concept of "risk reduction."2 However, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation. Given the increasing number of suffocation and other preventable sleep-related deaths and the fact that many of the behavioral risk factors for both SIDS and preventable sleep-related deaths are the same, providing parents with an additional safe sleep message that emphasizes prevention of suffocation may be more effective in changing parent behavior. Such a message would be carefully crafted based on our current community-based research1-3 to address emerging risks of greatest concern and potential self-efficacy. A simple, easily reproducible change in the system of newborn care could thus address a critical barrier to further progress in reducing infant mortality rates, particularly among African American families. The best systems of care to reduce disparities must use the best available and culturally competent messaging based on strong empirical evidence and require rigorous evaluation.
- Conditions
- Health Behavior
- Being tested
- Reduce Infant Mortality
- Keywords
- African American, Anticipatory Guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, sudden Infant Death Syndrome
- Medical subject headings
- Health Behavior, Infant Death, Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduce Infant MortalityBehavioural
Also called African Americans, Anticipatory guidance, Health Promotion, Infant Mortality
The study's long term goal is to disseminate a new easily implemented and reproducible intervention that based on our previous research is culturally competent and provides a rationale for changing infant sleep position and sleep environment. This intervention if successful will quickly be disseminated and will be an important change to the system of newborn care; the resultant change in parental behavior would ultimately result in a reduction in sleep-related infant mortality rates thereby promoting healthy development.After written consent has been obtained, a brief survey about knowledge of and attitudes toward safe sleep position recommendations, current intent with regards to safe sleep recommendations, and demographics will be completed. Contact information will be obtained from participants to facilitate study follow-up at two weeks of infants birth 2-3 months and 5-6 months.
| Study group | Role | What they receive |
|---|---|---|
| Reduce infant mortality | Other | The overall purpose of this study is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment Receives: Behavioral: Reduce Infant Mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suffocation, Strangulation and Sudden Infant Death Syndrome
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute, Medstar Health Research Institute
- Responsible party
- Principal investigator, Rachel Moon, MD, University of Virginia
- Investigators
- Rachel Y Moon, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361880
- Sponsor's protocol ID
- 2011-095
- Acronym
- SIDS
- Status last verified
- Jun 2017
- First submitted
- 12 May 2011
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moon RY, Mathews A, Joyner BL, Oden RP, He J, McCarter R. Health Messaging and African-American Infant Sleep Location: A Randomized Controlled Trial. J Community Health. 2017 Feb;42(1):1-9. doi: 10.1007/s10900-016-0227-1.
PubMed 27470122Mathews A, Joyner BL, Oden RP, He J, McCarter R Jr, Moon RY. Messaging Affects the Behavior of African American Parents with Regards to Soft Bedding in the Infant Sleep Environment: A Randomized Controlled Trial. J Pediatr. 2016 Aug;175:79-85.e2. doi: 10.1016/j.jpeds.2016.05.004. Epub 2016 Jun 2.
PubMed 27263400
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Messaging Trial to Reduce African-American Infant Mortality
- ClinicalTrials.gov ID
- NCT01361880
- Acronym / sponsor ID
- SIDS / 2011-095
- Conditions
- Health Behavior
- Keywords
- African American, Anticipatory Guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, sudden Infant Death Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Children's National Research Institute, Medstar Health Research Institute
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment. African-American parents of newborn, healthy term infants will be randomized to receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to prevent infant suffocation.
Detailed description
A persistent, significant racial disparity exists in infant mortality rates attributable to Sudden Infant Death Syndrome (SIDS) and other types of sleep-related sudden unexpected infant death (SUID), such as suffocation and undetermined causes of death. SIDS and other sleep-related deaths account for ~4600 U.S. deaths annually.4 While the incidence of SIDS has declined, infant deaths from accidental suffocation and strangulation in bed have quadrupled.5 Additionally, racial disparities in SIDS and other sleep-related deaths have increased over the past decade, with African-American infants twice as likely to die as other infants.6, 7 Certain infant sleeping practices, such as prone (stomach) sleeping, use of soft bedding and soft sleep surfaces, and bedsharing, likely play a significant role, both in SIDS and SUID, and in the disparities seen therein. Elimination of health barriers and racial/ethnic disparities, and promoting healthy development, have been highlighted as MCHB research priorities; this application is directly responsive to both of these priorities.
In the current system, health care providers and public health messages, using the American Academy of Pediatrics (AAP) recommendations,8 stress the use of supine (back) positioning, avoidance of soft bedding, and room sharing without bedsharing as recommendations to reduce the risk of SIDS. However, our research suggests that African-Americans have problems with this message, as they have a low degree of self-efficacy with regards to SIDS risk reduction (i.e., they do not believe that their actions can make a difference in whether SIDS occurs) and are suspicious of the concept of "risk reduction."2 However, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation. Given the increasing number of suffocation and other preventable sleep-related deaths and the fact that many of the behavioral risk factors for both SIDS and preventable sleep-related deaths are the same, providing parents with an additional safe sleep message that emphasizes prevention of suffocation may be more effective in changing parent behavior. Such a message would be carefully crafted based on our current community-based research1-3 to address emerging risks of greatest concern and potential self-efficacy. A simple, easily reproducible change in the system of newborn care could thus address a critical barrier to further progress in reducing infant mortality rates, particularly among African American families. The best systems of care to reduce disparities must use the best available and culturally competent messaging based on strong empirical evidence and require rigorous evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduce infant mortality | Other | Behavioral: Reduce Infant MortalityThe overall purpose of this study is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The purpose of the study is to determine the impact of a new educational strategy on African American parents, all participants will be self identified as African American. Although male parents will be allowed to participate in the followup surveys, female parents will be the primary focus of this study.
Key exclusion criteria (1 listed)
- Mothers under the age of 18 years will not be included in the study. Infants born with congenital anomalies that would prevent them from sleeping in the supine position or if the infant is born at less than 36 weeks gestation, requires hospitalization for more than 1 week, or has ongoing medical problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduce Infant MortalityAlso: African Americans, Anticipatory guidance, Health Promotion, Infant MortalityThe study's long term goal is to disseminate a new easily implemented and reproducible intervention that based on our previous research is culturally competent and provides a rationale for changing infant sleep position and sleep environment. This intervention if successful will quickly be disseminated and will be an important change to the system of newborn care; the resultant change in parental behavior would ultimately result in a reduction in sleep-related infant mortality rates thereby promoting healthy development.After written consent has been obtained, a brief survey about knowledge of and attitudes toward safe sleep position recommendations, current intent with regards to safe sleep recommendations, and demographics will be completed. Contact information will be obtained from participants to facilitate study follow-up at two weeks of infants birth 2-3 months and 5-6 months. | Behavioural | Reduce infant mortality |
Primary outcome
Suffocation, Strangulation and Sudden Infant Death Syndrome
Time frame: Three years
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 27470122Moon RY, Mathews A, Joyner BL, Oden RP, He J, McCarter R. Health Messaging and African-American Infant Sleep Location: A Randomized Controlled Trial. J Community Health. 2017 Feb;42(1):1-9. doi: 10.1007/s10900-016-0227-1.
- Derived from this study: PubMed 27263400Mathews A, Joyner BL, Oden RP, He J, McCarter R Jr, Moon RY. Messaging Affects the Behavior of African American Parents with Regards to Soft Bedding in the Infant Sleep Environment: A Randomized Controlled Trial. J Pediatr. 2016 Aug;175:79-85.e2. doi: 10.1016/j.jpeds.2016.05.004. Epub 2016 Jun 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Y Moon, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduce Infant Mortality in people with Health Behavior, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suffocation, Strangulation and Sudden Infant Death Syndrome (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01361880, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.