Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000310864
Ethics application status
Approved
Date submitted
6/03/2012
Date registered
20/03/2012
Date last updated
1/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of diet choice in long term weight reduction in type 2 diabetes
Scientific title
The choice of weight loss diet on long term results and long term study participation in type 2 diabetes
Secondary ID [1] 262256 0
None
Universal Trial Number (UTN)
U1111-1121-7500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus (type 2) 267952 0
Obesity 267953 0
Condition category
Condition code
Diet and Nutrition 268090 268090 0 0
Obesity
Metabolic and Endocrine 268091 268091 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants are randomly assigned to one of two groups for the 12 months of the intervention. The first group is placed on the CSIRO Total Well Being Diet (high protein, moderate carbs) with no option to change to an alternative regimen. The second group has the option to choose from the CSIRO Diet, the South Beach Diet (high protein, low carbs) or a Mediterranean-style diet (rich in olive oil, fish and fruit and veg) and also to change between these three regimens during the intervention. Adherence to the regimen is not measured other than through changes in body weight, HbA1c, lipids and so on. Food records are not kept by participants, nor are urine samples required. All participants, regardless of group, are monitored fortnightly at the clinic for weight loss/gain on an individual basis in the first 3 months and then every six weeks for the remainder of the study. The six-weekly visits also incorporate attendance with other study participants in small researcher-led group sessions. Blood tests are performed at 0, 3, 6 and 12 months.
Intervention code [1] 266647 0
Treatment: Other
Intervention code [2] 284407 0
Lifestyle
Comparator / control treatment
No choice of dietary weight loss regimen for the first group
Control group
Active

Outcomes
Primary outcome [1] 266834 0
Weight loss (kg) as assessed in the clinic using body weight scales
Timepoint [1] 266834 0
3, 6, 12 months
Primary outcome [2] 266882 0
Weight loss (% of body weight) as assessed in the clinic using body weight scales
Timepoint [2] 266882 0
3, 6, 12 months
Secondary outcome [1] 276475 0
HbA1c (% decrease) as measured by venous blood tests
Timepoint [1] 276475 0
3, 6, 12 months

Eligibility
Key inclusion criteria
BMI of 27 or greater
diagnosed with type 2 diabetes or pre-diabetes
on any medication, including insulin
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bariatric surgery

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)
Both the researcher who determiend if the subject was eligible for inclusion in the trial, and the subject, we not aware of which group the subject would be allocated to. Allocation was then centrally performed by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1) by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
different groups of participants receive different interventions ('choice' or 'no choice') during different time spans - recruitment of participants is rolling.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267178 0
Self funded/Unfunded
Name [1] 267178 0
Peter Clifton
Country [1] 267178 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart & Diabetes Institute
Address
75 Commercial Rd
Prahran 3004
Melbourne VIC
Country
Australia
Secondary sponsor category [1] 283716 0
Individual
Name [1] 283716 0
Peter Clifton
Address [1] 283716 0
Level 3,
193-195 North Terrace
Adelaide SA 5000

GPO Box 664 Adelaide SA 5001
Country [1] 283716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286827 0
The Alfred human Research Ethics Committee
Ethics committee address [1] 286827 0
Ground Floor, Linay Pavilion, The Alfred Hospital, Prahran, VIC, 3181
Ethics committee country [1] 286827 0
Australia
Date submitted for ethics approval [1] 286827 0
Approval date [1] 286827 0
Ethics approval number [1] 286827 0
Approval number 21/11

Summary
Brief summary
The research project aims to show by offering a choice of three different weight loss diets plus the ability to change diet styles throughout the study participants are more likely to remain in the study and more likely to achieve the study goals of a 10% weight loss at 12 months compared with those having usual clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32657 0
Address 32657 0
Country 32657 0
Phone 32657 0
Fax 32657 0
Email 32657 0
Contact person for public queries
Name 15904 0
Prof Peter Clifton
Address 15904 0
Level 3, 193-195 North Terrace Adelaide SA 5000 Australia
GPO Box 664 Adelaide SA 5001
Country 15904 0
Australia
Phone 15904 0
+61884629702
Fax 15904 0
Email 15904 0
[email protected]
Contact person for scientific queries
Name 6832 0
Prof Peter Clifton
Address 6832 0
Level 3, 193-195 North Terrace Adelaide SA 5000 Australia
GPO Box 664 Adelaide SA 5001
Country 6832 0
Australia
Phone 6832 0
+61884629702
Fax 6832 0
Email 6832 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
Dimensions AIPatient freedom to choose a weight loss diet in the treatment of overweight and obesity: a randomized dietary intervention in type 2 diabetes and pre-diabetes2014https://doi.org/10.1186/1479-5868-11-64
N.B. These documents automatically identified may not have been verified by the study sponsor.