ANZCTR - Registration

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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]

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)

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

No choice of dietary weight loss regimen for the first group

Control group

Active

Outcomes

Primary outcome [1]

Weight loss (kg) as assessed in the clinic using body weight scales

Timepoint [1]

3, 6, 12 months

Primary outcome [2]

Weight loss (% of body weight) as assessed in the clinic using body weight scales

Timepoint [2]

3, 6, 12 months

Secondary outcome [1]

HbA1c (% decrease) as measured by venous blood tests

Timepoint [1]

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?

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]

Self funded/Unfunded

Name [1]

Peter Clifton

Address [1]

Level 3,
193-195 North Terrace
Adelaide SA 5000

GPO Box 664 Adelaide SA 5001

Country [1]

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]

Individual

Name [1]

Peter Clifton

Address [1]

Level 3,
193-195 North Terrace
Adelaide SA 5000

GPO Box 664 Adelaide SA 5001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred human Research Ethics Committee

Ethics committee address [1]

Ground Floor, Linay Pavilion, The Alfred Hospital, Prahran, VIC, 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof Peter Clifton

Address

Level 3, 193-195 North Terrace Adelaide SA 5000 Australia
GPO Box 664 Adelaide SA 5001

Country

Australia

Phone

+61884629702

Fax

[email protected]

Contact person for scientific queries

Name

Prof Peter Clifton

Address

Level 3, 193-195 North Terrace Adelaide SA 5000 Australia
GPO Box 664 Adelaide SA 5001

Country

Australia

Phone

+61884629702

Fax

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Patient freedom to choose a weight loss diet in the treatment of overweight and obesity: a randomized dietary intervention in type 2 diabetes and pre-diabetes	2014	https://doi.org/10.1186/1479-5868-11-64

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

Trial Review

Documents added manually

Documents added automatically