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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.

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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

FieldValue
Enrollment Target 234 participants
Start Date 2018-03-04
Est. Completion 2021-07-05
Phase NA
University of Georgia

59 total trials

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.

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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Source: ClinicalTrials.gov NCT03505203, the US trial registry maintained by the National Library of Medicine. NCT03505203 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.