Healthy Sleeping and Feeding During Infancy
Completed · Phase 1
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00125580
- Run by
- Penn State University
- People needed
- 40
- Starts
- 2005-08-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2017-11-24
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥37 weeks gestation
- Primiparous mother (first pregnancy)
- Singleton
- Breast or bottle-fed
- Birth weight ≥2500 grams
You may not qualify if…
- <37 weeks gestation
- Multiparous mother {see above comment}
- Twin or multiple infant
- Birth weight <2500 grams
- Maternal conditions causing prolonged hospital stay or "non-routine" postpartum follow-up (except for diabetes mellitus: type 1, 2, or gestational)
- Infants with chronic illnesses or anomalies that require non-routine care or follow-up
Where it is running
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
- Penn State University — University Park, Pennsylvania, United States
Full record on ClinicalTrials.gov
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