Sleep-Safe: A Strong African American Families Study
Completed · Not applicable
Conditions studied: Weight Gain
In brief
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.
Key facts
- Study ID
- NCT03505203
- Run by
- University of Georgia
- People needed
- 234
- Starts
- 2018-03-04
- Expected to finish
- 2021-07-05
- Last updated by the study team
- 2025-02-06
Who can join
Age: 17 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Georgia — Athens, Georgia, United States
Full record on ClinicalTrials.gov
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