Trial from ANZCTR


Trial ID ACTRN12605000160639
Trial Status: Registered
Date Submitted: 11/08/2005
Date Registered: 16/08/2005
Retrospectively registered

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Public title 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.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Severe obesity 255 0
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Diet and nutrition Obesity
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287 287 0 0

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Descriptions of intervention(s) / exposure 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.
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Intervention Code:
Treatment: surgery 173 0
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Comparator / control treatment conventional weight loss management
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Control group Active
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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). 334 0
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Timepoint: At the end of the 2-year period following randomization 334 0
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Secondary Outcome: Difference in weight, height, skinfolds at triceps, minimal abdominal, maximal gluteal circumferences and neck circumference at the upper border of the thyroid cartilage. 755 0
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Timepoint: At 24 months. 755 0
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Secondary Outcome: Functional status using SF36, Multi-dimensional Body-Self Relation Questionnaire, Beck Depression Inventory, Child Health Questionnaire, Binge Eating Scale, Step Fitness (pedometers). 756 0
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Timepoint: At 6, 12 and 24 months. 756 0
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Secondary Outcome: Relationship of primary outcome with University of Rhode Island Change Assessment (URICA) Scale. 757 0
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Timepoint: At 2-years. 757 0
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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). 758 0
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Timepoint: At 6, 12 and 24 months. 758 0
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Secondary Outcome: Side effects of treatment with emphasis on compliance, peri-operative problems, postoperative vomiting, need for revisional procedures, cost of therapy for both arms. 759 0
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Timepoint: At 24 months 759 0
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Key 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.
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Minimum age 14 Years
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Maximum age 18 Years
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Gender Both males and females
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Healthy volunteers? No
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Key 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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Intervention recorded and stored in numbered, sealed opaque envelopes organized and maintained by staff member not involved in patient care or scheduling and opened in sequence as randomized.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Subjects were block randomized into 3 unequal blocks. Each block contained equal numbers in both treatment arms. The sequence within blocks was determined by the staff member in control of concealment by drawing the allocation out of a hat and the number in each blocking group was known only to this staff member.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 1/02/2005
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 50
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 341 0
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Name: NHMRC 341 0
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Address: Level 5, 20 Allara Street
Canberra ACT 2601
341 0
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Country: Australia 341 0
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Funding Source: Commercial sector/Industry 342 0
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Name: Inamed Health 342 0
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Address: 5540 Ekwill Street
Santa Barbara CA 93111
342 0
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Country: United States of America 342 0
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Funding Source: Hospital 343 0
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Name: Affinity Health 343 0
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Address: The Avenue Hospital
The Avenue, Windsor VIC 3181
343 0
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Country: Australia 343 0
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Primary Sponsor University
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Name: Monash University, School of Primary Health Care
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Address: Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
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Country: Australia
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Secondary Sponsor: None 271 0
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Name: none 271 0
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Address: 271 0
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Country: 271 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The Royal Children's Hospital, Melbourne 1288 0
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Address: Flemington Road Parkville Vic 3052 1288 0
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Country: Australia 1288 0
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Approval Date: 21/12/2004 1288 0
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Submitted Date: 1288 0
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HREC: EHRC24002B 1288 0
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Ethics Committee name: The Avenue Hospital, Melbourne 1289 0
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Address: The Avenue, Windsor Vic 3181 1289 0
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Country: Australia 1289 0
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Approval Date: 13/11/2003 1289 0
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Submitted Date: 1289 0
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HREC: Trial 047 1289 0
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Ethics Committee name: Monash University SCERH 1290 0
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Address: Building 3D, Clayton Campus Wellington Road
Clayton VIC
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Country: Australia 1290 0
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Approval Date: 17/03/2005 1290 0
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Submitted Date: 1290 0
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HREC: 2005/174MC 1290 0
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Brief summary
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Trial website
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Trial related presentations / publications O'Brien PE, Sawyer SM, Laurie C, Brown WA, Skinner S, Veit F, Paul E, Burton PR, McGrice M, Anderson M, Dixon JB. Laparoscopic Adjustable Gastric Banding in Adolescents: A Randomised Trial JAMA: 303 (6) 519-526
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Ms Cheryl Laurie
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Address: Centre for Obesity Research and Education (CORE) Monash University Medical School Alfred Hospital Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 3 99030721
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Fax: +61 3 95103365
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Email: cheryl.laurie@med.monash.edu.au
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Contact person for scientific queries
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Name: Associate Professor John Dixon
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Address: Monash University School of Primary Health Care Building 1, 270 Ferntree Gully Road Notting Hill 3168
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Country: Australia
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Tel: +61 3 9501 2431
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Fax: +61 3 8575 2233
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Email: john.dixon@med.monash.edu.au
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Contact person responsible for updating information
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Name: Mrs Maureen Dixon
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Address: Monash University School of Primary Health Care Building 1, 270 Ferntree Gully Road Notting Hill 3168
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Country: Australia
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Tel: +61 3 8575 2273
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Fax: +61 3 8575 2233
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Email: maureen.dixon@med.monash.edu.au
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Addition Cancer fields
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