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NCT03505203 · ClinicalTrials.gov registry record · NA
Sleep-Safe: A Strong African American Families Study
A NA study, sponsored by University of Georgia.
- Completed
- Registry status
- NA
- Development phase
- 234
- Enrollment target
NCT03505203: Completed NA study, sponsored by University of Georgia.
NCT03505203 is a NA study that has completed, run by University of Georgia. The registered enrollment target is 234 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03505203, a NA study, has completed, sponsored by University of Georgia.
- COMPLETED
- Registry status
- NA
- Development phase
- 234 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Sleep Soothe
- BEHAVIORAL Sleep Safe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2018-03-04 |
| Est. Completion | 2021-07-05 |
| Phase | NA |
What the finished NCT03505203 record still lists
NCT03505203 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Sleep Soothe is the first listed.
NCT03505203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03505203 about?
NCT03505203 is a clinical study titled "Sleep-Safe: A Strong African American Families Study". 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 whethe...
What is the current status of trial NCT03505203?
This trial is currently completed. It is a NA study. The enrollment target is 234 participants. The study started on 2018-03-04. Estimated completion is 2021-07-05.
What interventions are being tested in trial NCT03505203?
The interventions under investigation include: Sleep Soothe (BEHAVIORAL), Sleep Safe (BEHAVIORAL).
Who is sponsoring clinical trial NCT03505203?
This trial is sponsored by University of Georgia, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03505203's enrollment target sits among peer trials
234 462nd of 2000 higher than 1,538 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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