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.

Monash University, School of Primary Health Care0 sites50 target enrollmentAugust 16, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 16, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Monash University, School of Primary Health Care

•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 analysis that requires fasting venous sampling.

•Lack of acceptance of the randomization process, history of previous abdominal surgery which would potentially preclude laparascopic placement of the band, a history of previous obesity surgery, any contraindication to Lap\-Band placement history of previous abdominal surgery which would potentially preclude laparascopic placement of the band, unsuitability for the Active8 peer support program, medical issues which contraindicated the application of either arm of the study (these would include; acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure) , systemic lupus erythematosis or other auto\-immune disease, direct hypothalamic damage as a cause of obesity, inability to understand the risks, realistic benefits and compliance requirements of the Lap\-Band intervention and conventional management of severe obesity, Prader\-Willi syndrome or other syndromes associated with intellectual disability or hyperphagia.