Status:
COMPLETED
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gerber Products Company
Conditions:
Weight Gain
Obesity
Eligibility:
All Genders
1-12 years
Phase:
PHASE1
Brief Summary
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 interve...
Detailed Description
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 S...
Eligibility Criteria
Inclusion
- \> 34 0/7 weeks gestational age
- Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
- Singleton infant
- Nursery or NICU stay of 7 days or less
- Primiparous mother
- Maternity stay of 7 days or less
- Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
- Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
- English speaking mother.
Exclusion
- Newborn nursery, NICU, or maternity stay \> 7 days
- Exclusive formula feeding in the nursery or NICU
- Multiparous mother
- Any metabolic condition that requires feedings at precise intervals
- Gestational age of 33 6/7 weeks or less
- Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
- Non-singleton newborn
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00359242
Start Date
June 1 2006
End Date
December 1 2009
Last Update
July 28 2017
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850