Status:
COMPLETED
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
Lead Sponsor:
Ian M. Paul, MD
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Infant
Obesity
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention wi...
Detailed Description
Principal Hypotheses: An intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle will prevent rapid weight gai...
Eligibility Criteria
Inclusion
- full-term infant(\> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
- singleton infant
- nursery/NICU/maternity stay of 7 days or less
- primiparous mother
- English speaking mother
Exclusion
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
- maternal age \<=20 years
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight \<2500 grams plan for newborn to be adopted
- plan to move from Central Pennsylvania within 3 years
- inability to complete contact form with name, address, phone numbers, etc.
- Practicing pediatrician or pediatric resident
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT01167270
Start Date
January 1 2012
End Date
December 31 2023
Last Update
January 31 2024
Active Locations (2)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
2
Penn State University
State College, Pennsylvania, United States, 16802