CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 234 enrolled
Drug / intervention
Sleep Soothe +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03505203
NCT03505203N/ACompleted

Sleep-Safe: A Strong African American Families Study

University of Georgia·interventional·Posted Apr 23, 2018·Updated Feb 6, 2025

In Brief

A clinical study evaluating Sleep Soothe and Sleep Safe for Weight Gain. Completed, enrolled 234 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Gain
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 23, 2018
Enrollment StartMar 4, 2018
Primary CompletionJul 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.2 years ago

Interventions

Sleep Soothebehavioral

An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.

Sleep Safebehavioral

An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.