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Trial registered on ANZCTR


Registration number
ACTRN12613000250730
Ethics application status
Approved
Date submitted
1/03/2013
Date registered
4/03/2013
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of dietary intake in people with type 1 and type 2 diabetes
Scientific title
Validation of the DQES (V2) food frequency questionnaire for measurement of dietary intake in people with type 1 and type 2 diabetes
Secondary ID [1] 282053 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 and type 2 diabetes 288529 0
Condition category
Condition code
Diet and Nutrition 288862 288862 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 288863 288863 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Validation of the DQES (V2) food frequency questionnaire against a 3 day weighed food record and 24 hour urine sample in people with type 1 and type 2 diabetes. The study will invole 2 study visits. At the first visit participants will complete the DQES (V2) food frequency questionnaire and be told how to complete a weighed food record. At the second visit the participants will bring in a completed 24 hour urine sample and 3 day weighed food record. The food record will be checked. Study visits will be approximately 1 week apart.
Intervention code [1] 286646 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288988 0
Does the DQES (V2) Food Frequency Questionnaire accurately measure dietary intake in people with type 1 and type 2 diabetes compared to a 3 day weighed food record?
Timepoint [1] 288988 0
End of study
Secondary outcome [1] 301509 0
Does the DQES (V2) Food Frequency Questionnaire accurately measure dietary intake of sodium and potassium compared to a 24 hour urine sample?
Timepoint [1] 301509 0
End of study

Eligibility
Key inclusion criteria
Diagnosed type 1 or type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer
Signficant liver disease of any degree
Signficant renal failure i.e. eGFR <30ml/min

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6450 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286826 0
University
Name [1] 286826 0
University of South Australia
Address [1] 286826 0
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country [1] 286826 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] 285617 0
None
Name [1] 285617 0
Address [1] 285617 0
Country [1] 285617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288892 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288892 0
GPO Box 2471
Adelaide
SA 5001
Ethics committee country [1] 288892 0
Australia
Date submitted for ethics approval [1] 288892 0
26/02/2013
Approval date [1] 288892 0
Ethics approval number [1] 288892 0
0000031247
Ethics committee name [2] 304924 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [2] 304924 0
GPO Box 2471, Adelaide SA 5001,
Ethics committee country [2] 304924 0
Australia
Date submitted for ethics approval [2] 304924 0
25/02/2013
Approval date [2] 304924 0
13/03/2013
Ethics approval number [2] 304924 0
31247

Summary
Brief summary
Weighed food records are considered the gold standard for determining dietary intake. Twenty hour urine samples are the gold standard for measuring sodium and potassium intake. However, these methods are burdensome to complete. The DQES (V2) food frequency questionnaire, a much less burdensome method of measuring dietary intake, has been previously validated in non-diabetic populations, however there has been no validation in people with diabetes.
Trial website
Trial related presentations / publications
Petersen KS, Smith JM, Clifton PM, Keogh JB, 2015, Dietary intake in adults with Type 1 and Type 2 Diabetes: validation of the Dietary Questionnaire for Epidemiological Studies version 2 Food Frequency Questionnaire against a 3 day weighed food record and 24 hour urinalysis, Br J Nutr. 114(12):2056-63
Public notes

Contacts
Principal investigator
Name 38250 0
A/Prof Jennifer Keogh
Address 38250 0
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country 38250 0
Australia
Phone 38250 0
+61 8 8302 2579
Fax 38250 0
Email 38250 0
Jennifer.Keogh@unisa.edu.au
Contact person for public queries
Name 38251 0
A/Prof Jennifer Keogh
Address 38251 0
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country 38251 0
Australia
Phone 38251 0
+61 8 8302 2579
Fax 38251 0
Email 38251 0
Jennifer.Keogh@unisa.edu.au
Contact person for scientific queries
Name 38252 0
A/Prof Jennifer Keogh
Address 38252 0
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country 38252 0
Australia
Phone 38252 0
+61 8 8302 2579
Fax 38252 0
Email 38252 0
Jennifer.Keogh@unisa.edu.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6095 0
Petersen, K., Smith, J., Clifton, P., & Keogh, J. (2015). Dietary intake in adults with type 1 and type 2 diabetes: Validation of the Dietary Questionnaire for Epidemiological Studies version 2 FFQ against a 3-d weighed food record and 24-h urinalysis. British Journal of Nutrition, 114(12), 2056-2063. doi:10.1017/S0007114515003748
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Participants were sixty-seven adults with type 1 and type 2 diabetes recruited
from the community. Nutrient intake reported in the Food Frequency Questionnaire (FFQ) was within 20 % of the corresponding intake level reported in the Weighed Food Record (WFR) for the majority of nutrients. However, the 95 % limits of agreement showed large variation at an individual level between the two methods. There was a weak to moderate correlation between nutrient intake measured using the two methods and a moderate to high correlation for food intake. Sodium (Na) intake was under-estimated in the FFQ by 25 % and Potassium (K) intake was over-estimated by 5 % compared with the 24-h urinalysis. In adults with type 1 and type 2 diabetes, it is appropriate to use the DQES v2 FFQ to measure food and nutrient intake at a group level.