Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001192774
Ethics application status
Approved
Date submitted
25/10/2013
Date registered
30/10/2013
Date last updated
10/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Attitudes and beliefs of dietary intake and health risks in people with type 1 & type 2 diabetes
Scientific title
Attitudes and beliefs of dietary intake and health risks in people with type 1 & type 2 diabetes
Secondary ID [1] 283447 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 290363 0
Type 2 Diabetes 290364 0
Condition category
Condition code
Diet and Nutrition 290755 290755 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 290777 290777 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will attend the University of South Australia on one occassion, for approximately 45 minutes, and have their weight and height measured, complete the questionnaire and provide a spot urine sample

A questionnaire based on the one used by Grimes et al 2009 will be used to determine in people with type 1 and type 2 diabetes:
- The knowledge of the health risks associated with dietary intake
- Ability to interpret the nutrition information on Australian food labels
- The frequency of use of nutrition labelling on food products
- The influence nutrition panels have on shopping behaviour
Urinary electrolyte excretion will be measured using a single random spot urine sample. The association between excretion and reported dietary intake of sodium and potassium (using a food frequency questionnaire) will be investigated. In addition, the correlation between the questionnaire responses and excretion will be examined.
Body mass index will be derived from weight and height measured on one occasion and glycated hemoglobin A1c will be self-reported by the participants or obtained by accessing medical records. The relationship between questionnaire responses and BMI and HbA1c will be investigated.
Intervention code [1] 288163 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290752 0
Questionnaire, adapted from the one used by Grimes et al 2009, which assesses attitudes and beliefs of people with diabetes to: the health risks associated with dietary intake, interpretation of nutrition labelling, how nutrition labels influence shopping behaviour
Timepoint [1] 290752 0
Each participant will fill in a questionnaire on one occassion only
Secondary outcome [1] 305171 0
The relationship between urinary sodium and potassium excretion measured using a random spot urine sample and questionnaire (adapted from Grimes et al 2009) responses.
Timepoint [1] 305171 0
Each participant will provide one random spot urine sample and complete the questionnaire on one occassion only.
Secondary outcome [2] 305172 0
The relationship between dietary intake, measured by a food frequency questionnaire (Cancer Council of Victoria’s Food Frequency Questionnaire), and questionnaire responses (adapted from Grimes et al 2009)
Timepoint [2] 305172 0
Each participant will complete the food frequency questionnaire and questionnaire on one occassion only
Secondary outcome [3] 305173 0
The relationship between BMI, derived from weight and height measured on one occassion, and glycated hemoglobin A1c (self-reported or obtained from medical records) and questionnaire responses (adapted from Grimes et al 2009)
Timepoint [3] 305173 0
Each participant will have their weight and height measured on one occassion and a recently measured HbA1c result will be provided
Secondary outcome [4] 305190 0
The relationship between urinary sodium and potassium intake, measured in a random spot urine sample and reported dietary intake, measured using a food frequency questionnaire
Timepoint [4] 305190 0
Each participant will provide a random spot urine sample and complete the food frequency questionnaire on one occassion

Eligibility
Key inclusion criteria
Diagnosed type 1 or type 2 diabetes for any duration
Able to understand the study protocol and complete the questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not diagnosed with type 1 or type 2 diabetes

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/03/2013
Date of last participant enrolment
Anticipated
31/12/2013
Actual
17/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1611 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7495 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288162 0
University
Name [1] 288162 0
University of South Australia
Country [1] 288162 0
Australia
Funding source category [2] 288167 0
Charities/Societies/Foundations
Name [2] 288167 0
Geld Gum Bequest, Endocrine Unit
Royal Adelaide Hospital
Country [2] 288167 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] 286884 0
None
Name [1] 286884 0
Address [1] 286884 0
Country [1] 286884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290078 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 290078 0
PO Box 2471
Adelaide
SA 5001
Ethics committee country [1] 290078 0
Australia
Date submitted for ethics approval [1] 290078 0
Approval date [1] 290078 0
14/03/2014
Ethics approval number [1] 290078 0
31264
Ethics committee name [2] 290079 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [2] 290079 0
Level 3, Hanson Institute IMVS Building
North Terrace
Adelaide SA 5000
Ethics committee country [2] 290079 0
Australia
Date submitted for ethics approval [2] 290079 0
Approval date [2] 290079 0
27/02/2013
Ethics approval number [2] 290079 0
130209

Summary
Brief summary
To investigate in a cohort of people with type 1 and type 2 diabetes:
- The knowledge of the health risks associated with dietary intake
- Ability to interpret the nutrition information on Australian food labels
- The frequency of use of nutrition labelling on food products
- The influence nutrition panels has on shopping behaviour
- Urinary electrolyte excretion and the association this has with dietary intake
- Usual dietary intake
- Body mass index and HbA1c in association with the above information
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43830 0
A/Prof Jennifer Keogh
Address 43830 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 43830 0
Australia
Phone 43830 0
+61 8 8302 2579
Fax 43830 0
Email 43830 0
[email protected]
Contact person for public queries
Name 43831 0
A/Prof Jennifer Keogh
Address 43831 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 43831 0
Australia
Phone 43831 0
+61 8 8302 2579
Fax 43831 0
Email 43831 0
[email protected]
Contact person for scientific queries
Name 43832 0
A/Prof Jennifer Keogh
Address 43832 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 43832 0
Australia
Phone 43832 0
+61 8 8302 2579
Fax 43832 0
Email 43832 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
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