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Sleep-Safe: a Strong African American Families Study

NCT03505203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-02-06

No results posted yet for this 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.

Conditions

  • Weight Gain

Interventions

BEHAVIORAL

Sleep Soothe

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

BEHAVIORAL

Sleep Safe

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

Sponsors & Collaborators

  • Augusta University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Georgia

    lead OTHER

Principal Investigators

  • Justin A Lavner, Ph.D. · University of Georgia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-04
Primary Completion
2021-07-05
Completion
2021-07-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505203 on ClinicalTrials.gov