None listed
Conditions
Interventions
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.
Sponsors
Monash University, School of Primary Health Care
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
14 Years to 18 Years
Healthy volunteers
No
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 analysis that requires fasting venous sampling.
Exclusion criteria
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.
Outcome results
None listed