Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125580
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2005-07-29
Brief Title:
Healthy Sleeping and Feeding During Infancy
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Healthy Sleeping and Feeding During Infancy Pilot Study for the Primary Prevention of Obesity in Primary Care
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 103 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 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
Detailed Description:
The objective of this proposal is to test in a primary care setting the effect of an established intervention designed to promote healthy feeding and sleeping behaviors early in life on risk factors for subsequent obesity Because nocturnal feeding of infants short sleep duration and childhood obesity are linked the procedure is designed to prevent short sleep duration and subsequently accelerated weight gain during infancy two emerging risk factors for obesity in childhood and adulthood In this study 40 participants will be randomized to receive either an intervention that teaches infants to sleep through the night by 8 weeks of age or standard care The procedure instructs parents to offer a focal feed before bedtime avoid feeding as the first alternative to infant waking and distress and carry out environmental control measures that emphasize daynight differences In assessing the impact of the intervention night wakening and rate of weight gain will be assessed between birth and 4 months of age The current proposal will test the feasibility of delivering this proven intervention in the primary care setting an environment that must be included in primary preventive strategies for childhood obesity
Aim 1 To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care
This procedure which instructs parents to offer a focal feed before bedtime avoid feeding as the first alternative to infant waking and distress and carry out environmental control measures that emphasize daynight differences has been successful at prolonging sleep duration in experimental settings By demonstrating that subjects can be recruited from the newborn nursery be taught the procedure at a primary care visit and followed for four months the feasibility of a larger study will be more apparent to external funding agencies
Aim 2 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
It is hypothesized that the positive effect of the procedure in an experimental setting will be replicated in a randomized controlled trial in the primary care setting By definition teaching infants to sleep through the night will be manifest in longer sleep duration which has been shown to be protective for childhood obesity in epidemiological studies Sleeping through the night is hypothesized to promote protective factors for childhood obesity by supporting
Aim 1 To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care
This procedure which instructs parents to offer a focal feed before bedtime avoid feeding as the first alternative to infant waking and distress and carry out environmental control measures that emphasize daynight differences has been successful at prolonging sleep duration in experimental settings By demonstrating that subjects can be recruited from the newborn nursery be taught the procedure at a primary care visit and followed for four months the feasibility of a larger study will be more apparent to external funding agencies
Aim 2 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
It is hypothesized that the positive effect of the procedure in an experimental setting will be replicated in a randomized controlled trial in the primary care setting By definition teaching infants to sleep through the night will be manifest in longer sleep duration which has been shown to be protective for childhood obesity in epidemiological studies Sleeping through the night is hypothesized to promote protective factors for childhood obesity by supporting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None