Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000287932
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
18/03/2011
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost-effectiveness of weight loss for type 2 diabetics: a randomised controlled trial of LapBand placement
Scientific title
Cost-effectiveness of weight loss for type 2 diabetics: a randomised controlled trial of LapBand placement
Secondary ID [1] 259797 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 237154 0
Condition category
Condition code
Diet and Nutrition 237480 237480 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was placement of a LapBand in patients to folow them and see how much weight they lose. The LapBand procedure takes approximately 30 minutes. The control did not recieve a LapBand. Weight loss was measured by weight lost in kilograms and BMI lost, as well as blood measurements. This trial went for 12 months.
An economic analysis of in terms of a cost-effectiveness analysis will be implemented in this phase. This will involve an estimation of costs associated with both groups (eg., Cost of the Lapband procedure etc)
Intervention code [1] 236868 0
Treatment: Surgery
Comparator / control treatment
THe control group did not recieve a LapBand, they recieved normal medical care.
Control group
Active

Outcomes
Primary outcome [1] 238285 0
Weight loss: change in weight in kilograms and BMI
Timepoint [1] 238285 0
fortnightly at timepoints up to 2 yrs
Secondary outcome [1] 244660 0
Cost effectiveness. Estimation by economist of QALYs DALYs etc after a consideration of costs of surgery, aftercare etc
Timepoint [1] 244660 0
Continuous uo to 2 yrs

Eligibility
Key inclusion criteria
1. obese (BMI >30)
2. undergone bariatric surgery
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. previous stomach surgery
2. aged > 60 years

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
11/05/2015
Date of last participant enrolment
Anticipated
Actual
10/10/2016
Date of last data collection
Anticipated
Actual
28/11/2016
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237257 0
Government body
Name [1] 237257 0
National Health and Medical Research Council (NHMRC)
Country [1] 237257 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Obesity Research & Education
Address
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country
Australia
Secondary sponsor category [1] 263829 0
University
Name [1] 263829 0
Monash University
Address [1] 263829 0
Clayton Campus
Wellington Road
Monash University
Victoria 3800
Australia
Country [1] 263829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239360 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 239360 0
Ethics committee country [1] 239360 0
Australia
Date submitted for ethics approval [1] 239360 0
Approval date [1] 239360 0
04/09/2003
Ethics approval number [1] 239360 0

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

Contacts
Principal investigator
Name 29843 0
Dr Dr. John Wentworth
Address 29843 0
Centre for Obesity Research and Eduacation
The Alfred Centre
99 Commercial Rd
Melbourne. VIC 3004
Country 29843 0
Australia
Phone 29843 0
+61 3 99030724
Fax 29843 0
Email 29843 0
[email protected]
Contact person for public queries
Name 13090 0
Cheryl Laurie
Address 13090 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 13090 0
Australia
Phone 13090 0
+61 3 99030750
Fax 13090 0
Email 13090 0
[email protected]
Contact person for scientific queries
Name 4018 0
John Wentworth
Address 4018 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 4018 0
Australia
Phone 4018 0
+61 3 99030750
Fax 4018 0
Email 4018 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator,


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
No additional documents have been identified.