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| ID | Type | Description | Link |
|---|---|---|---|
| Grant Number: R56DK072996 |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Gerber Products Company | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Soothing and Calming instructions given at 2 weeks of life |
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| 2 | Experimental | Repeated food exposure instructions given between 4 and 6 months of life |
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| 3 | Experimental | Receive both interventions: Soothing and Calming and Repeated food exposure |
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| 4 | No Intervention | Group receiving neither of the interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Sleeping and Soothing | Behavioral | Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of infants sleeping 5 consecutive hours at night at 2 months of age | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration breastfed | 2 years | |
| Rate of weight gain | 2.5 years | |
| Self-regulation of emotion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leann Birch, PhD | Penn State University | Principal Investigator |
| Ian M Paul, MD, MSc | Milton S. Hershey Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20725058 | Derived | Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19. |
| Label | URL |
|---|---|
| Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research Office | View source |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Repeated Food Exposure | Behavioral | Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age. |
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| 3 years |
| Timing of introduction of solids | 3 years |
| Infant dietary variety | 3 years |
| Maternal feeding style | 3 years |
| Infant temperament | 3 years |
| Body Composition | 3 years |
| Lab evaluation | 5 years |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |