Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000052235
Ethics application status
Approved
Date submitted
9/12/2017
Date registered
16/01/2018
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of choice in weight loss.
Scientific title
The effect on weight loss of choosing a weight loss strategy in overweight and obese adults.
Secondary ID [1] 293573 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 305811 0
Type 2 diabetes 306146 0
Condition category
Condition code
Metabolic and Endocrine 305028 305028 0 0
Diabetes
Diet and Nutrition 305260 305260 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be allocated to a 'Choice Group' which will give participants the opportunity to choose between either a 5 & 2 dietary strategy (5 days of habitual eating with 2 very low energy intake days of 2000 - 3000kJ/day) or continuous energy restriction dietary strategy (daily energy restriction between 4000-5000kJ/day).

Participants will be asked to follow the diet for 8 weeks and attend the Sansom CTF at the start for randomisation and dietary instruction and every two weeks for 8 weeks. They will have height measured once and weight measured on each occasion. The first visit will take approximately 30 minutes and subsequent visits will take 15 minutes.
The intervention will be delivered to participants individually by a research assistant under the supervision of a Dr Keogh who is a qualifeid dietitian. Eduation material with a detailed description of the chosen diet and how to follow it will be provided to the participants. Participants will have weight measured individually every two weeks when they attend the Sansom Clinical Trial Facility. All participants will be asked to keep food diaries for 3 days/week while they are in the study.
Intervention code [1] 299823 0
Lifestyle
Intervention code [2] 299906 0
Behaviour
Comparator / control treatment
Control group will see participants follow a 5 &2 dietary intervention strategy (5 days of habitual eating with 2 very low energy intake days of 2000 - 3000kJ/day) for the duration of the trial. Eduation material with a detailed description of the diet and how to follow it will be provided to the participants.
Participants will be asked to follow the diet for 8 weeks and attend the Sansom CTF at the start for randomisation and dietary instruction and every two weeks for 8 weeks. They will have height measured once and weight measured on each occasion. The first visit will take approximately 30 minutes and subsequent visits will take 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 304192 0
Weight measured by digital weigh scales
Timepoint [1] 304192 0
The primary variable to be measured will be weight loss. This will be measured at 0 and at 2, 4, 6 and 8 weeks post-intervention commencement
Secondary outcome [1] 341180 0
No secondary outcomes will be measured.
Timepoint [1] 341180 0
N/A

Eligibility
Key inclusion criteria
18 years of age or over,
Body Mass Index >27kg/m 2 and <50kg/m 2,
Type 2 diabetes controlled by diet alone or agents that do not cause hypoglycaemia.
In good health assessed by self report.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or Breastfeeding
Unable to understand study protocol
Unable to adhere to dietary intervention for the 8 week period.
Previous history of weight loss 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)
Allocation once eligibility for inclusion was decided involved contacting the holder of the allocation schedule who was another member of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be performed using the statistics program SPSS for Windows. Significance will be set at P < 0.05. Analyses of variance with repeated measures (with group as the within subject factor) will be used, with and without covariates including age, BMI, and gender.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/11/2017
Date of last participant enrolment
Anticipated
25/01/2018
Actual
25/01/2018
Date of last data collection
Anticipated
22/03/2018
Actual
23/03/2018
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 18270 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298185 0
University
Name [1] 298185 0
University of South Australia
Country [1] 298185 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 1269
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 297285 0
None
Name [1] 297285 0
Address [1] 297285 0
Country [1] 297285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299200 0
University Of South Australia
Ethics committee address [1] 299200 0
Ethics committee country [1] 299200 0
Australia
Date submitted for ethics approval [1] 299200 0
24/01/2017
Approval date [1] 299200 0
08/02/2017
Ethics approval number [1] 299200 0
0000036413

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

Contacts
Principal investigator
Name 79630 0
A/Prof Jennifer Keogh
Address 79630 0
School of Pharmacy and Medical Sciences, University of South Australia
Frome Rd
Adelaide
SA 5000
GPO Box 1269
Adelaide SA 5001
Country 79630 0
Australia
Phone 79630 0
+61 8 830 22579
Fax 79630 0
Email 79630 0
[email protected]
Contact person for public queries
Name 79631 0
Jennifer Keogh
Address 79631 0
School of Pharmacy and Medical Sciences, University of South Australia
Frome Rd
Adelaide
SA 5000
GPO Box 1269
Adelaide SA 5001
Country 79631 0
Australia
Phone 79631 0
+61 8 830 22579
Fax 79631 0
Email 79631 0
[email protected]
Contact person for scientific queries
Name 79632 0
Jennifer Keogh
Address 79632 0
School of Pharmacy and Medical Sciences, University of South Australia
Frome Rd
Adelaide
SA 5000
GPO Box 1269
Adelaide SA 5001
Country 79632 0
Australia
Phone 79632 0
+61 8 830 22579
Fax 79632 0
Email 79632 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.