The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study

Completed · Not applicable

Conditions studied: Infant, Obesity

In brief

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 will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.

Key facts

Study ID

NCT01167270

Run by

Ian M. Paul, MD

People needed

316

Starts

2012-01-01

Expected to finish

2023-12-31

Last updated by the study team

2024-01-31

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Penn State University — State College, Pennsylvania, United States

Full record on ClinicalTrials.gov

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