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NCT00125580 · ClinicalTrials.gov registry record · Phase 1
Healthy Sleeping and Feeding During Infancy
A Phase 1 study of Obesity, sponsored by Penn State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT00125580 is a Phase 1 study of Obesity that has completed, run by Penn State University. The registered enrollment target is 40 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00125580, a Phase 1 study of Obesity, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
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.
NCT00125580 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
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.
What interventions are being tested in trial NCT00125580?
The interventions under investigation include: Infant sleep instruction (BEHAVIORAL).
Who is sponsoring clinical trial NCT00125580?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.