ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Prediction of weight outcome following VLED using a linear discriminant analysis (LDA) model

Timepoint [1]

12 months after weight loss

Primary outcome [2]

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]

12 months after weight loss

Secondary outcome [1]

nil

Timepoint [1]

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]

University

Name [1]

University of Melbourne, Department of Medicine (Austin Health)

Address [1]

Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg VIC 3081

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
Studley Rd
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/11/2013

Ethics approval number [1]

Summary

Brief summary

Amongst people undertaking any weight loss program, there is considerable variation in the amount of weight lost.  Many studies have attempted to predict the outcome of weight loss treatments from information about biological, behavioural and psychological factors collected from participants before the start of treatment, but it has been difficult to predict outcomes using current methods.  In a previous study conducted in our research group, we examined a statistical method which appeared to be useful in predicting the outcome of a medically supervised very-low-energy diet program using participants’ baseline physical measurements and psychological characteristics.  However, further research is required in order to create a tool which will be useful to patients and healthcare providers.  The overall aim of this study is to create a statistical model which can accurately predict the result for a person about to start a weight loss program.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Joseph Proietto

Address

University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 2250

Fax

j.proietto@unimelb.edu.au

Contact person for public queries

Name

Priya Sumithran

Address

University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 2250

Fax

priyas@unimelb.edu.au

Contact person for scientific queries

Name

Priya Sumithran

Address

University of Melbourne, Dept of Medicine (Austin Health)
Level 2, Boronia Building, Heidelberg Repatriation Hospital
300 Waterdale Rd, Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 2250

Fax

priyas@unimelb.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Combining biological and psychosocial baseline variables did not improve prediction of outcome of a very-low-energy diet in a clinic referral population.	2018	https://dx.doi.org/10.1111/cob.12229

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically