Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Type of registration
Retrospectively registered

Titles & IDs
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.
Scientific 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.
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Severe obesity 255 0
Condition category
Condition code
Diet and nutrition 287 287 0 0

Study type
Description 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.
Intervention code [1] 173 0
Treatment: surgery
Comparator / control treatment
conventional weight loss management
Control group

Primary outcome [1] 334 0
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).
Timepoint [1] 334 0
At the end of the 2-year period following randomization
Secondary outcome [1] 755 0
Difference in weight, height, skinfolds at triceps, minimal abdominal, maximal gluteal circumferences and neck circumference at the upper border of the thyroid cartilage.
Timepoint [1] 755 0
At 24 months.
Secondary outcome [2] 756 0
Functional status using SF36, Multi-dimensional Body-Self Relation Questionnaire, Beck Depression Inventory, Child Health Questionnaire, Binge Eating Scale, Step Fitness (pedometers).
Timepoint [2] 756 0
At 6, 12 and 24 months.
Secondary outcome [3] 757 0
Relationship of primary outcome with University of Rhode Island Change Assessment (URICA) Scale.
Timepoint [3] 757 0
At 2-years.
Secondary outcome [4] 758 0
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).
Timepoint [4] 758 0
At 6, 12 and 24 months.
Secondary outcome [5] 759 0
Side effects of treatment with emphasis on compliance, peri-operative problems, postoperative vomiting, need for revisional procedures, cost of therapy for both arms.
Timepoint [5] 759 0
At 24 months

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.
Minimum age
14 Years
Maximum age
18 Years
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Closed: follow-up complete
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 341 0
Government body
Name [1] 341 0
Address [1] 341 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country [1] 341 0
Funding source category [2] 342 0
Commercial sector/Industry
Name [2] 342 0
Inamed Health
Address [2] 342 0
5540 Ekwill Street
Santa Barbara CA 93111
Country [2] 342 0
United States of America
Funding source category [3] 343 0
Name [3] 343 0
Affinity Health
Address [3] 343 0
The Avenue Hospital
The Avenue, Windsor VIC 3181
Country [3] 343 0
Primary sponsor type
Monash University, School of Primary Health Care
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Secondary sponsor category [1] 271 0
Name [1] 271 0
Address [1] 271 0
Country [1] 271 0

Ethics approval
Ethics application status
Ethics committee name [1] 1288 0
The Royal Children's Hospital, Melbourne
Ethics committee address [1] 1288 0
Flemington Road Parkville Vic 3052
Ethics committee country [1] 1288 0
Date submitted for ethics approval [1] 1288 0
Approval date [1] 1288 0
Ethics approval number [1] 1288 0
Ethics committee name [2] 1289 0
The Avenue Hospital, Melbourne
Ethics committee address [2] 1289 0
The Avenue, Windsor Vic 3181
Ethics committee country [2] 1289 0
Date submitted for ethics approval [2] 1289 0
Approval date [2] 1289 0
Ethics approval number [2] 1289 0
Trial 047
Ethics committee name [3] 1290 0
Monash University SCERH
Ethics committee address [3] 1290 0
Building 3D, Clayton Campus Wellington Road
Clayton VIC
Ethics committee country [3] 1290 0
Date submitted for ethics approval [3] 1290 0
Approval date [3] 1290 0
Ethics approval number [3] 1290 0

Brief summary
Trial website
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
Public notes

Principal investigator
Name 35428 0
Address 35428 0
Country 35428 0
Phone 35428 0
Fax 35428 0
Email 35428 0
Contact person for public queries
Name 9362 0
Ms Cheryl Laurie
Address 9362 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9362 0
Phone 9362 0
+61 3 99030721
Fax 9362 0
+61 3 95103365
Email 9362 0
Contact person for scientific queries
Name 290 0
Associate Professor John Dixon
Address 290 0
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country 290 0
Phone 290 0
+61 3 9501 2431
Fax 290 0
+61 3 8575 2233
Email 290 0