Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000258954
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
9/03/2011
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a low energy diet using meal replacements before surgery for weight loss
Scientific title
Evaluation of a pre-operative meal replacement program in bariatric surgery patients
Secondary ID [1] 259743 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 261327 0
Condition category
Condition code
Diet and Nutrition 259472 259472 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As part of usual care, patients will be advised to consume 2 commercially available meal replacements, either a shake or a bar, for two meals a day and a commercially available energy controlled normal meal for one meal a day. Patients will also be advised about fruit and vegetable intake and recommended to have two and five serves respectively. Duration of the diet will be prescribed on an individual basis for between 2-6 weeks prior to surgery.
The overall duration of the study will be six months. Patients will be recruited as they are assessed as being eligible for surgery. Each patient will be observed for up to six weeks.
Intervention code [1] 264173 0
Not applicable
Comparator / control treatment
An additional group of patients that had bariatric surgery between January 1st 2010 and April 18th 2011 will also be invited to participate in the study. They will be identified by their treating physician and if appropriate, will be contacted by phone to ask if they would like to participate. If written approval is received they will be contacted again by phone and interviewed about their weight loss and their compliance with the diet.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262283 0
Weight Loss
Weight loss will be assessed using weighing scales.
Timepoint [1] 262283 0
Zero and Six Weeks
Secondary outcome [1] 273456 0
Liver Function Tests.
Liver function tests to be measured are GGT, ALP, AST, ALT and Bilirubin and will be measured by a certified commercial laboratory.
Timepoint [1] 273456 0
Zero and Six Weeks

Eligibility
Key inclusion criteria
Body Mass Index (BMI) > 40 kg/m2 or > 35 kg/m2 and one obesity related illness/comorbidity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not suitable for bariatric surgery

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Project did not go ahead.
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 3858 0
5000

Funding & Sponsors
Funding source category [1] 264620 0
Self funded/Unfunded
Name [1] 264620 0
Country [1] 264620 0
Primary sponsor type
University
Name
University of South Australia
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 263758 0
University
Name [1] 263758 0
University of South Australia
Address [1] 263758 0
North Terrace, Adelaide SA 5000
Country [1] 263758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266624 0
University of South Australia
Ethics committee address [1] 266624 0
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 266624 0
Australia
Date submitted for ethics approval [1] 266624 0
21/03/2011
Approval date [1] 266624 0
28/03/2011
Ethics approval number [1] 266624 0
Ethics committee name [2] 266979 0
Calvary Hospital
Ethics committee address [2] 266979 0
North Adelaide
Ethics committee country [2] 266979 0
Australia
Date submitted for ethics approval [2] 266979 0
Approval date [2] 266979 0
19/04/2011
Ethics approval number [2] 266979 0
New ethics HREC. Please modify.
Ethics committee name [3] 266980 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [3] 266980 0
Bedford Park, South Australia
Ethics committee country [3] 266980 0
Australia
Date submitted for ethics approval [3] 266980 0
Approval date [3] 266980 0
02/05/2011
Ethics approval number [3] 266980 0
New ethics HREC. Please modify.

Summary
Brief summary
The purpose of this study is to assess the effect of the pre-operative very low energy diet on liver function tests and weight loss, and to correlate these outcomes with compliance to the program. Our hypotheses are:
1. Pre-operative weight loss will be associated with an improvement in liver function tests
2. Increased compliance to the program will be associated with greater weight loss
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32317 0
A/Prof Jennifer Keogh
Address 32317 0
University of South Australia North Terrace Adelaide, SA 5000
Country 32317 0
Australia
Phone 32317 0
+61 8 8302 2579
Fax 32317 0
Email 32317 0
[email protected]
Contact person for public queries
Name 15564 0
Assoc Prof Jennifer Keogh
Address 15564 0
University of South Australia
North Terrace
Adelaide, SA 5000
Country 15564 0
Australia
Phone 15564 0
+61 8 8302 2579
Fax 15564 0
Email 15564 0
[email protected]
Contact person for scientific queries
Name 6492 0
Assoc Prof Jennifer Keogh
Address 6492 0
University of South Australia
North Terrace
Adelaide, SA 5000
Country 6492 0
Australia
Phone 6492 0
+61 8 8302 2579
Fax 6492 0
Email 6492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD data will be available as this was not approved by ethics.


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.