Study population We plan to enroll 30 subjects between the ages of 14 and 17 years with the LAP-BAND®. The inclusion criteria are in accordance with recent evidence-based indications for the surgical management of severe obesity in the pediatric population (Pratt, Lenders et al. 2009). The enrollees will be children who have a body-mass index in the 99th percentile, corresponding to a BMI\>= 35 kg/m2, and who exhibit significant comorbidities.
This sample size will provide over 90% power to detect a 15% change in body mass index with a standard deviation of 6, two-tailed alpha of 0.05, and allow for 20% loss to follow-up, using a paired design.
