Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001015336
Ethics application status
Not required
Date submitted
10/07/2017
Date registered
14/07/2017
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trends in dietary sodium from food sources in Australian children and adolescents from 2007 to 2011/12
Scientific title
Trends in dietary sodium from food sources in Australian children and adolescents from 2007 to 2011/12
Secondary ID [1] 292400 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary sodium intake 303966 0
Condition category
Condition code
Diet and Nutrition 303319 303319 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Dietary sodium intake was assessed via 24hr dietary recall methods (exposure). The outcome of this study is assessing the change in sodium intake between study years 2007 and 2011/12.
For the 2007 study i.e. 2007 Children's Nutrition and Physical Activity Survey (CNPAS)) data was collected during Feb-Aug 2007.
For the 2011/12 study i.e. the 2011/12 National Nutrition and Physical Activity Survey (NNPAS)) data was collected May 2011- June 2012.
Intervention code [1] 298571 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302705 0
Change in sodium intake (mg/d) assessed by 24hr dietary recall.
Timepoint [1] 302705 0
Change assessed during period 2007 and 2011/12.
Primary outcome [2] 302706 0
Change in sodium density (mJ/d) assessed via 24hr dietary recall.
Timepoint [2] 302706 0
Change assessed during period 2007 to 2011/12.
Primary outcome [3] 302719 0
Change in the proportion of children exceeding the daily recommended Upper Level for sodium intake assessed via 24hr dietary recall.
Timepoint [3] 302719 0
Change assessed during period 2007 to 2011/12.
Secondary outcome [1] 336783 0
Change in the contribution of sodium from food groups assessed via 24hr dietary recall. Food groups will be defined using the Food Standards Australia and New Zealand food group classification system specific which corresponds to each survey year food composition database i.e. AUSNUT 2007 and AUSNUT 2011-13 .
Timepoint [1] 336783 0
Change assessed during period 2007 and 2011/12.
Secondary outcome [2] 336803 0
Change in the contribution of sodium from ‘core’ and ‘discretionary’ foods assessed via 24hr dietary recall. The Australian Guide to Healthy Eating will be used to define and group foods as either 'core' or 'discretionary'.
Timepoint [2] 336803 0
Change assessed during period 2007 and 2011/12.

Eligibility
Key inclusion criteria
2007 CNPAS: Australian children aged 2-16 years
2011/12 NNPAS: Australian children aged 2-16 years
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
2007 CNPAS: Children living in households in very remote areas were excluded from the sampling selection framework. Participants identified as low energy reporters.
2011/12 NNPAS: Children living in households in very remote areas were excluded from the sampling selection framework. Participants identified as low energy reporters.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis
2007 CNPAS: The target quota for each of the following age groups: 2-3, 4-8, 9-13 and 14-16 years was 1000 participants, to which a 400 booster sample was later provided by the state of South Australia to provide more detailed estimates for that state. This study was designed and conducted by Commonwealth Scientific Industrial Research Organisation (CSIRO) and University of South Australia and no power calculations are provided.

2011/12 NNPAS: The sample was designed to ensure that within each state or territory, each person had an equal chance of selection and that reliable estimates could be produced for each state and territory. A total of 12,153 people participated in the survey. To enable comparison to the 2007 CNPAS survey, our analysis is restricted to children aged 2-16 years (n=2548). The NNPAS was conducted by the Australian Bureau of Statistics and no power calculations are provided.

Analysis Plan:
Analyses will account for complex survey design of both surveys (i.e. population weightings, clustering, stratification). A two-sample t-test will be used to compare differences in continuous variables across survey years and a two-sample test of proportions will be used to assess differences in categorical variables across survey years. For food group analysis, differences in the contribution of sodium from food groups will be assessed by examination of survey design adjusted 95% confidence intervals. PC-Side will be used to estimate usual sodium intake and the proportion of children who consume more than the age-specific dietary recommendation, adjustments will be made for day type of diet recall and dietary recall sequence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/09/2014
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
6948
Accrual to date
Final
7385
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296952 0
Charities/Societies/Foundations
Name [1] 296952 0
Heart Foundation of Australia
Country [1] 296952 0
Australia
Funding source category [2] 296960 0
University
Name [2] 296960 0
Deakin University
Country [2] 296960 0
Australia
Primary sponsor type
Individual
Name
Carley Ann Grimes
Address
Deakin University, Institute for Physical Activity and Nutrition, Locked Bag 20000, Waurn Ponds, Geelong, VIC 3220,
Country
Australia
Secondary sponsor category [1] 295964 0
None
Name [1] 295964 0
Address [1] 295964 0
Country [1] 295964 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298157 0
Ethics committee address [1] 298157 0
Ethics committee country [1] 298157 0
Date submitted for ethics approval [1] 298157 0
Approval date [1] 298157 0
Ethics approval number [1] 298157 0

Summary
Brief summary
The aim of this study was to assess trends in sodium intake from food sources among Australian children and adolescents from 2007 to 2011-12. To do this we have completed secondary data analysis of two existing data sets, the 2007 CNPAS and the 2011/12 NNPAS.
Trial website
Trial related presentations / publications
None
Public notes
This study is secondary analysis of available national nutrition data-sets and no ethical approval for this study/analysis is required.

Contacts
Principal investigator
Name 76174 0
Dr Carley Ann Grimes
Address 76174 0
Deakin University, Institute for Physical Activity and Nutrition, Locked Bag 20000, Waurn Ponds, Geelong, VIC 3220, Australia
Country 76174 0
Australia
Phone 76174 0
+6139246223
Fax 76174 0
Email 76174 0
[email protected]
Contact person for public queries
Name 76175 0
Carley Ann Grimes
Address 76175 0
Deakin University, Institute for Physical Activity and Nutrition, Locked Bag 20000, Waurn Ponds, Geelong, VIC 3220, Australia
Country 76175 0
Australia
Phone 76175 0
+61392446223
Fax 76175 0
Email 76175 0
[email protected]
Contact person for scientific queries
Name 76176 0
Carley Ann Grimes
Address 76176 0
Deakin University, Institute for Physical Activity and Nutrition, Locked Bag 20000, Waurn Ponds, Geelong, VIC 3220, Australia
Country 76176 0
Australia
Phone 76176 0
+61392446223
Fax 76176 0
Email 76176 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.