Healthy Sleeping and Feeding During Infancy
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|ClinicalTrials.gov Identifier: NCT00125580|
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : November 24, 2017
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Infant sleep instruction||Phase 1|
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 day/night 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 day/night 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Healthy Sleeping and Feeding During Infancy: Pilot Study for the Primary Prevention of Obesity in Primary Care|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- The rate of sleeping through the night at 8 weeks of age between treatment groups (intervention versus standard treatment)
- Across the study period, infant weight gain will be measured to study differences between treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125580
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Penn State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Ian Paul, MD, MSc||Milton S. Hershey Medical Center|