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Healthy Sleeping and Feeding During Infancy
NCT00125580 · View on ClinicalTrials.gov ↗
Study Summary
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests obesity in childhood and adulthood may often originate from accelerated weight gain during infancy. Further data are accumulating that link short sleep duration with obesity during childhood and later life. Prospective data are lacking that demonstrate whether the accelerated weight gain during infancy can be prevented and whether interventions to improve sleep early in life can prevent childhood obesity. Key Objectives: The key objectives are: * To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care; and * To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.
Conditions Studied
Interventions
- BEHAVIORAL Infant sleep instruction
Study Locations (2)
Pennsylvania
- Penn State Milton S Hershey Medical Center — Hershey
- Penn State University — University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125580
The ClinicalTrials.gov registry entry for NCT00125580 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 233 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention — of which Infant sleep instruction is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00125580 reports 2 study locations spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00125580 about?
NCT00125580 is a clinical study titled "Healthy Sleeping and Feeding During Infancy". Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from...
What is the current status of trial NCT00125580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-08. Estimated completion is 2006-12.
What conditions does trial NCT00125580 study?
This clinical trial studies the following conditions: Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00125580?
The interventions under investigation include: Infant sleep instruction (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00125580?
This trial is sponsored by Penn State University, which has 233 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00125580 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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