Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000197639
Ethics application status
Approved
Date submitted
14/02/2014
Date registered
24/02/2014
Date last updated
21/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating a novel method to predict weight outcome after a weight loss program
Scientific title
Investigating a novel method to predict weight outcome after a Very-low-energy diet (VLED)-based weight loss program in obese adults
Secondary ID [1] 284101 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 291176 0
Condition category
Condition code
Diet and Nutrition 291514 291514 0 0
Obesity
Metabolic and Endocrine 291515 291515 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake an 8-week modified very-low-energy diet (VLED), in which 2 meals per day will be replaced with a commercially available very-low-energy diet formulation (Optifast VLCD milkshake or bar), along with a third meal consisting of lean protein and up to 2 cups of low-starch vegetables. At least 30 minutes per day of moderate intensity physical activity will be advised for all participants.
After a 2-week transition period in which participants will consume 1 meal replacement and 2 meals, participants will cease the meal replacements and be instructed to follow a weight maintenance diet individualised for their energy requirements for weight maintenance for one year.
Participants will be seen by a study physician or dietician every 2 weeks during the VLED phase, and every two months during the weight maintenance phase. At these visits, participants' weight, hip and waist circumferences will be measured, and dietary and exercise goals/advice will be reinforced. Beyond this, no specific strategies or tools will be used to improve or monitor adherence to the intervention protocols, in order to replicate a clinical setting as far as possible.
Intervention code [1] 288796 0
Treatment: Other
Intervention code [2] 288825 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291485 0
Prediction of weight outcome following VLED using a linear discriminant analysis (LDA) model
Timepoint [1] 291485 0
12 months after weight loss
Primary outcome [2] 291486 0
Re-evaluation of the predictive accuracy of the LDA model after incorporation of data regarding biological and psychosocial factors (obtained via anthropometric measurements, biochemical testing and questionnaires).
Timepoint [2] 291486 0
12 months after weight loss
Secondary outcome [1] 306885 0
nil
Timepoint [1] 306885 0
N/A

Eligibility
Key inclusion criteria
Weight stable for 3 months
BMI greater than/equal to 30kg/m2 or BMI greater than/equal to 27kg/m2 with a medical condition related to excess weight
BMI less than 60kg/m2
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy or breast-feeding
Previous surgery for weight loss
The use of a VLED or weight-lowering medication in the past 3 months
Change in weight of 3kg or more in the past 3 months
Change in dosage of thyroid or other hormone replacement in past 3 months
Planned surgery during the study
Cessation of smoking in past 6 months
Uncontrolled or clinically significant disease which would be a contraindication to a VLED
Known alcohol or drug dependence in past 1 year

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
This is a non-randomised, single arm dietary intervention trial in which participants will undertake an 8-week VLED-based weight loss diet followed by 12 months on a weight-maintenance diet.
At the end of the study, participants will fall into one of 3 categories: those who lost at least 10% of their initial weight during the VLED and maintained their weight loss (maintaining at least 70% of initial weight loss at week 60), those who lost at least 10% of their initial weight during the VLED but regained the lost weight (regained >30% of initial weight lost), and those who did not lose 10% of their initial weight, or who did not complete the study.
Using the participants’ baseline anthropometric, biochemical and psychosocial questionnaire data, we will examine the ability of a statistical (linear discriminant analysis) model to predict the weight outcome 12 months after initial weight loss.
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2014
Actual
25/02/2014
Date of last participant enrolment
Anticipated
Actual
4/02/2015
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288734 0
University
Name [1] 288734 0
University of Melbourne, Department of Medicine (Austin Health)
Country [1] 288734 0
Australia
Primary sponsor type
University
Name
University of Melbourne, Department of Medicine (Austin Health)
Address
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg VIC 3081
Country
Australia
Secondary sponsor category [1] 287431 0
None
Name [1] 287431 0
Address [1] 287431 0
Country [1] 287431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290569 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 290569 0
Ethics committee country [1] 290569 0
Australia
Date submitted for ethics approval [1] 290569 0
Approval date [1] 290569 0
21/11/2013
Ethics approval number [1] 290569 0

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

Contacts
Principal investigator
Name 46286 0
Prof Joseph Proietto
Address 46286 0
University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 46286 0
Australia
Phone 46286 0
+61 3 9496 2250
Fax 46286 0
Email 46286 0
[email protected]
Contact person for public queries
Name 46287 0
Priya Sumithran
Address 46287 0
University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 46287 0
Australia
Phone 46287 0
+61 3 9496 2250
Fax 46287 0
Email 46287 0
[email protected]
Contact person for scientific queries
Name 46288 0
Priya Sumithran
Address 46288 0
University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 46288 0
Australia
Phone 46288 0
+61 3 9496 2250
Fax 46288 0
Email 46288 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
EmbaseCombining biological and psychosocial baseline variables did not improve prediction of outcome of a very-low-energy diet in a clinic referral population.2018https://dx.doi.org/10.1111/cob.12229
N.B. These documents automatically identified may not have been verified by the study sponsor.