Sleep-Safe: a Strong African American Families Study
2 other identifiers
interventional
234
1 country
1
Brief Summary
Rapid weight gain during infancy is a powerful, and potentially malleable, risk factor for later overweight and obesity, but limited research has examined the impact of promising interventions when applied to the groups most at risk for rapid weight gain in infancy. The present study examines whether providing mothers of newborns with responsive parenting guidance during the first weeks of life to promote infant sleep and soothing can reduce rapid weight gain for African American infants born in low SES contexts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2018
CompletedFirst Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2021
CompletedFebruary 6, 2025
October 1, 2022
3.3 years
April 3, 2018
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain)
Standardized residuals from the linear regression of weight for age at 16 weeks on weight for age at 3 weeks, with length for age at birth and 16 weeks and infant age at the 16-week assessment entered as covariates
3 weeks to 16 weeks
Secondary Outcomes (4)
Change in infants' weight for age
3 weeks to 16 weeks
Weight-for-age z scores
16 weeks
Weight-for-length z scores
16 weeks
Infant BMI z scores
16 weeks
Other Outcomes (16)
Maternal report of infant sleep at 8 weeks
8 weeks
Maternal report of infant sleep at 16 weeks
16 weeks
Maternal sleep actigraphy
8 weeks postpartum
- +13 more other outcomes
Study Arms (2)
Sleep Soothe
EXPERIMENTALAn intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
Sleep Safe
ACTIVE COMPARATORAn intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe
Interventions
An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.
Eligibility Criteria
You may qualify if:
- Infant \> 37 0/7 weeks gestational age, apparently healthy and without significant morbidity
- Singleton infant
- Nursery/NICU/maternity stay of 7 days or less
- Mother at least 17 years of age
- Mother self-identifies as African American
- Mother is primiparous
You may not qualify if:
- Non-English speaking
- Infant birth weight \<2500 grams
- Presence of a congenital anomaly or neonatal physical or metabolic condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- Any major maternal morbidities, pre-existing condition that would affect postpartum care or her ability to care for her newborn (e.g., narcotic drug use: heroin, cocaine, meth, pain pills, etc; on chemotherapy; uncontrolled MS; uncontrolled depression causing social service contact).
- Plan for newborn to be adopted
- Plan to move from area within four months of delivery
- Residence further than 75 miles from Augusta, GA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Georgialead
- Augusta Universitycollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (1)
University of Georgia
Athens, Georgia, 30602, United States
Related Publications (11)
Lavner JA, Hohman EE, Beach SRH, Stansfield BK, Savage JS. Effects of a Responsive Parenting Intervention Among Black Families on Infant Sleep: A Secondary Analysis of the Sleep SAAF Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e236276. doi: 10.1001/jamanetworkopen.2023.6276.
PMID: 37000448BACKGROUNDHohman EE, Savage JS, Stansfield BK, Lavner JA. Sleep SAAF Responsive Parenting Intervention for Black Mothers Impacts Response to Infant Crying: A Randomized Clinical Trial. Acad Pediatr. 2024 Jan-Feb;24(1):97-104. doi: 10.1016/j.acap.2023.04.012. Epub 2023 May 5.
PMID: 37148966BACKGROUNDHart AR, Beach SRH, Hart CN, Smith JJ, Stansfield BK, Lavner JA. Responsive parenting and Black mothers' postpartum sleep: Secondary analysis of a randomized controlled trial. Health Psychol. 2024 Jun;43(6):438-447. doi: 10.1037/hea0001363. Epub 2024 Feb 8.
PMID: 38330306BACKGROUNDWeber DM, Bryant CM, Williamson HC, Mussa K, Lavner JA. Predictors of change in relationship satisfaction among Black postpartum mothers. Fam Process. 2024 Jun;63(2):768-787. doi: 10.1111/famp.12990. Epub 2024 Mar 28.
PMID: 38548477BACKGROUNDWeber DM, Williamson HC, Bryant CM, Mussa KS, Lavner JA. Patterns and predictors of change in relationship status among Black mothers over 16 weeks postpartum. J Fam Psychol. 2024 Aug;38(5):751-762. doi: 10.1037/fam0001238. Epub 2024 Jun 17.
PMID: 38884990BACKGROUNDAdesogan O, Beach SRH, Carter SE, Metzger IW, Lavner JA. Effects of a responsive parenting intervention on Black mothers' depressive symptoms postpartum: Secondary analysis of a randomized clinical trial. J Consult Clin Psychol. 2024 Dec;92(12):828-835. doi: 10.1037/ccp0000926.
PMID: 39715425BACKGROUNDMoore AM, Smith JJ, Stansfield BK, Savage JS, Lavner JA. Patterns and Predictors of Breast Milk Feeding from Birth to Age 4 Months among Primiparous African American Mother-Infant Dyads. Nutrients. 2022 Jun 4;14(11):2350. doi: 10.3390/nu14112350.
PMID: 35684150BACKGROUNDLavner JA, Savage JS, Stansfield BK, Beach SRH, Marini ME, Smith JJ, Sperr MC, Anderson TN, Hernandez E, Moore AM, Caldwell AL, Birch LL. Effects of the Sleep SAAF responsive parenting intervention on rapid infant weight gain: A randomized clinical trial of African American families. Appetite. 2022 Aug 1;175:106080. doi: 10.1016/j.appet.2022.106080. Epub 2022 May 13.
PMID: 35577176BACKGROUNDHernandez E, Lavner JA, Moore AM, Stansfield BK, Beach SRH, Smith JJ, Savage JS. Sleep SAAF responsive parenting intervention improves mothers' feeding practices: a randomized controlled trial among African American mother-infant dyads. Int J Behav Nutr Phys Act. 2022 Oct 1;19(1):129. doi: 10.1186/s12966-022-01366-1.
PMID: 36183135BACKGROUNDLavner JA, Stansfield BK, Beach SRH, Brody GH, Birch LL. Sleep SAAF: a responsive parenting intervention to prevent excessive weight gain and obesity among African American infants. BMC Pediatr. 2019 Jul 5;19(1):224. doi: 10.1186/s12887-019-1583-7.
PMID: 31277694BACKGROUNDHart AR, Beach SRH, Hart CN, Metzger IW, Lavner JA. Effects of contextual stress on Black mothers' self-reported and actigraph-estimated postpartum sleep. Sleep. 2025 Jul 11;48(7):zsaf023. doi: 10.1093/sleep/zsaf023.
PMID: 40036969DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin A Lavner, Ph.D.
University of Georgia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 23, 2018
Study Start
March 4, 2018
Primary Completion
July 5, 2021
Study Completion
July 5, 2021
Last Updated
February 6, 2025
Record last verified: 2022-10