A Phase 1 interventional study of Infant Sleeping and Soothing and Repeated Food Exposure in Weight Gain and Obesity, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 1 Day to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by Milton S. Hershey Medical Center · Phase 1, Interventional, and Other
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Rationale: 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 between 2003-2004, a staggering 26.2% of children aged 2 to 5 years were already overweight or at-risk for overweight. As such, in the summary of the "Conference on Preventing Childhood Obesity," it was remarked that researchers should particularly consider the youngest of children when planning obesity related interventions. Because the current evidence base regarding potentially effective early intervention components is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Key Objectives:
Aim 1: To evaluate the effect of simple procedures, taught to parents in the home environment by visiting nurses, that trains parents to calm their infants and increase their nocturnal sleep duration, thereby influencing sleep duration, nocturnal feeding frequency, and weight gain during infancy.
Aim 2: To evaluate a simple training procedure for parents, taught in the home environment by visiting nurses, that promotes infants' acceptance of nutritious, developmentally appropriate weaning foods.
Aim 3: To evaluate the delivery of these behavioral interventions to parents by community based home health nurses.
Aim 4: To examine the effect of a soothing intervention designed to increase sleep duration on overall maternal regulation of emotion, self-regulation of emotion, and weight gain.
Study Population: 160 newborns and mothers that demonstrate intent to breastfeed during the newborn nursery stay will be recruited during the maternity hospitalization. Approximately 25-50 physicians from the university affiliated pediatric and family practices.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 160 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Soothing and Calming instructions given at 2 weeks of life
Behavioral: Infant Sleeping and Soothing
Repeated food exposure instructions given between 4 and 6 months of life
Behavioral: Repeated Food Exposure
Receive both interventions: Soothing and Calming and Repeated food exposure
Behavioral: Infant Sleeping and Soothing · Behavioral: Repeated Food Exposure
Group receiving neither of the interventions.
Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Time frame: 2.5 years
Duration breastfed
Time frame: 2 years
Rate of weight gain
Time frame: 2.5 years
Self-regulation of emotion
Time frame: 3 years
Timing of introduction of solids
Time frame: 3 years
Infant dietary variety
Time frame: 3 years
Maternal feeding style
Time frame: 3 years
Infant temperament
Time frame: 3 years
Body Composition
Time frame: 3 years
Lab evaluation
Time frame: 5 years
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center