Healthy Sleeping and Feeding During Infancy
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/25/2017 |
| Start Date: | August 2005 |
| End Date: | December 2006 |
Healthy Sleeping and Feeding During Infancy: Pilot Study for the Primary Prevention of Obesity in Primary Care
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.
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.
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
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
Inclusion Criteria:
- ≥37 weeks gestation
- Primiparous mother (first pregnancy)
- Singleton
- Breast or bottle-fed
- Birth weight ≥2500 grams
Exclusion Criteria:
- <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
We found this trial at
2
sites
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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