Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000748819
Ethics application status
Approved
Date submitted
12/07/2012
Date registered
13/07/2012
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to determine the effect of nutrition education on dietary intake in people with diabetes
Scientific title
The effect of nutrition education on biomarkers of dietary intake in people with diabetes
Secondary ID [1] 280842 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes (type 1 & 2) 286908 0
Condition category
Condition code
Diet and Nutrition 287230 287230 0 0
Other diet and nutrition disorders
Public Health 287239 287239 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3 month randomised controlled trial. Participants in the intervention group will be advised to increase their consumption of fruit (1 extra serve/day), vegetables (2 extra serves/day) and dairy (1 extra serve/day). Participants will choose which fruit, vegetables and dairy products they would like to increase their intake of.
Intervention code [1] 285264 0
Treatment: Other
Intervention code [2] 285267 0
Lifestyle
Comparator / control treatment
The control group will not receive any dietary advice and will continue to consume their usual diet
Control group
Active

Outcomes
Primary outcome [1] 287516 0
Urinary potassium excretion as a biomarker of fruit and vegetable consumption
Timepoint [1] 287516 0
Baseline and 3 months
Primary outcome [2] 287521 0
Biomarkers of dairy intake (palmitoleic acid, pentadeconic acid and heptadecanoic acid)
Timepoint [2] 287521 0
Baseline and 3 months
Primary outcome [3] 287522 0
Plasma carotenoids will be measured as a biomarker of fruit and vegetable consumption
Timepoint [3] 287522 0
Baseline and 3 months
Secondary outcome [1] 298306 0
Change in dietary intake measured by the food frequency questionnaire
Timepoint [1] 298306 0
baseline and 3 months
Secondary outcome [2] 298315 0
Blood pressure measured by automated sphygmomanometer (mean of 3 measures)
Timepoint [2] 298315 0
Baseline and 3 months

Eligibility
Key inclusion criteria
Patients with type 1 and type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiovascular disease requiring active intervention such as CABG or stenting in the next 3-4 months
Heart failure of any degree
Cancer
Significant renal impairment i.e. eGFR <30ml/min

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be publically advertised. Participants will be randomised by computer generated random numbers to either the intervention or control group. Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using a computer program
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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
10/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 5534 0
5000

Funding & Sponsors
Funding source category [1] 285625 0
University
Name [1] 285625 0
University of South Australia
Country [1] 285625 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284460 0
None
Name [1] 284460 0
Address [1] 284460 0
Country [1] 284460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287622 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 287622 0
Ethics committee country [1] 287622 0
Australia
Date submitted for ethics approval [1] 287622 0
Approval date [1] 287622 0
11/07/2012
Ethics approval number [1] 287622 0
29376

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

Contacts
Principal investigator
Name 34433 0
Address 34433 0
Country 34433 0
Phone 34433 0
Fax 34433 0
Email 34433 0
Contact person for public queries
Name 17680 0
Associate Professor Jennifer Keogh
Address 17680 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 500
Country 17680 0
Australia
Phone 17680 0
+61 8 8302 2579
Fax 17680 0
Email 17680 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 8608 0
Associate Professor Jennifer Keogh
Address 8608 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 500
Country 8608 0
Australia
Phone 8608 0
+61 8 8302 2579
Fax 8608 0
Email 8608 0
jennifer.keogh@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.