Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000160639
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
16/08/2005
Date last updated
2/12/2010
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
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 341 0
Government body
Name [1] 341 0
NHMRC
Country [1] 341 0
Australia
Funding source category [2] 342 0
Commercial sector/Industry
Name [2] 342 0
Inamed Health
Country [2] 342 0
United States of America
Funding source category [3] 343 0
Hospital
Name [3] 343 0
Affinity Health
Country [3] 343 0
Australia
Primary sponsor type
University
Name
Monash University, School of Primary Health Care
Address
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country
Australia
Secondary sponsor category [1] 271 0
None
Name [1] 271 0
none
Address [1] 271 0
Country [1] 271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1288 0
The Royal Children's Hospital, Melbourne
Ethics committee address [1] 1288 0
Ethics committee country [1] 1288 0
Australia
Date submitted for ethics approval [1] 1288 0
Approval date [1] 1288 0
21/12/2004
Ethics approval number [1] 1288 0
EHRC24002B
Ethics committee name [2] 1289 0
The Avenue Hospital, Melbourne
Ethics committee address [2] 1289 0
Ethics committee country [2] 1289 0
Australia
Date submitted for ethics approval [2] 1289 0
Approval date [2] 1289 0
13/11/2003
Ethics approval number [2] 1289 0
Trial 047
Ethics committee name [3] 1290 0
Monash University SCERH
Ethics committee address [3] 1290 0
Ethics committee country [3] 1290 0
Australia
Date submitted for ethics approval [3] 1290 0
Approval date [3] 1290 0
17/03/2005
Ethics approval number [3] 1290 0
2005/174MC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 9362 0
+61 3 99030721
Fax 9362 0
+61 3 95103365
Email 9362 0
[email protected]
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
Australia
Phone 290 0
+61 3 9501 2431
Fax 290 0
+61 3 8575 2233
Email 290 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLaparoscopic adjustable gastric banding in severely obese adolescents: A randomized trial.2010https://dx.doi.org/10.1001/jama.2010.81
N.B. These documents automatically identified may not have been verified by the study sponsor.