A prospective randomized controlled intervention study of conventional management versus the placement of the Lap-Band System in severely obese adolescents in effecting weight loss.

INTERVENTION: A group of 50 severely obese adolescents will be randomized to either a conventional management plan incorporating the Active8 Adolescent Program with dietary and behavioural modification or surgical management with the Lap‐Band System. CONDITION: Severe obesity PRIMARY OUTCOME: Percentage of patients who achieve a weight loss of 50% of excess BMI corrected for age. The initial BMI will be adjusted for age (Z‐score). SECONDARY OUTCOME: Changes in comorbidities (including hypertension, impaired fasting glucose,hyperinsulinaemia, insulin resistance and pancreatic beta cell function, dyslipidaemia, clinical polycystic ovary syndrome, markers for obesity related liver dysfunction (NAFLD), obstructive sleep apnoea, excessive daytime sleepiness and asthma). Difference in weight, height, skinfolds at triceps, minimal abdominal, maximal gluteal circumferences and neck circumference at the upper border of the thyroid cartilage. Functional status using SF36, Multi‐dimensional Body‐Self Relation Questionnaire, Beck Depression Inventory, Child Health Questionnaire, Binge Eating Scale, Step Fitness (pedometers). Relationship of primary outcome with University of Rhode Island Change Assessment (URICA) Scale. Side effects of treatment with emphasis on compliance, peri‐operative problems, postoperative vomiting, need for revisional procedures, cost of therapy for both arms. INCLUSION CRITERIA: Have a body mass index greater than 35kg/m2 corrected for age, that is a z‐score of 3.0 or greater, have had identifiable problems with obesity for more than 3 years, self‐motivated with a good grasp of English and able to clearly understand the nature of a randomized treatment program, be able to understand the options and study requirements and comply with both of the management programs, be able to give informed consent to either program, be willing to be randomized, have the support of a parent or guardian who understands the nature and requirements of both treatment arms and is fully supportive of the decision of the adolescent to enter the randomized study, willingness of the parent or guardian to give informed consent to either arm. The subject and parent or guardian partners would understand the requirements of the study itself, including the need for serial simple anthropometric measurements, completion of serial questionnaires and serial biochemical analys