Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12619000198123
Ethics application status
Not required
Date submitted
6/02/2019
Date registered
12/02/2019
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between lifestyle behaviours and anxiety in the Australian population
Scientific title
Diet, physical activity and anxiety: an Australian population representative study
Secondary ID [1] 297326 0
Nil
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Anxiety 311434 0
Condition category
Condition code
Mental Health 310073 310073 0 0
Anxiety
Public Health 310117 310117 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Australian Health Survey 2014 - 2015 will be used for this analysis. The data collected pertain to health conditions (including mental health conditions), diet and physical activity behaviours, and demographic information. The data were cross-sectional, collected during 2014 and 2015.
Intervention code [1] 313577 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318968 0
Mental health conditions are assessed by the following item;
I would now like to ask you about mental health, behavioural and cognitive conditions.
When answering these questions, please include any conditions [you are/[first name] is] currently managing with treatment or medication.
If answered Yes, the following was asked;
Which ones?
More than one response is allowed. Press space bar between responses.
10. Depression, including Persistent depressive disorder
11. Feeling depressed
12. Bipolar disorder
13. Mania
14. Anxiety disorder
15. Feeling anxious, nervous or tense
16. Panic disorder
17. Panic attacks
18. Post-Traumatic Stress Disorder (PTSD)
19. Agoraphobia
20. Obsessive-Compulsive Disorder (OCD)
21. Social Phobia
22. Other affective or anxiety condition – please specify]
Timepoint [1] 318968 0
Data provided at survey collection time
Secondary outcome [1] 366556 0
Nil
Timepoint [1] 366556 0
Nil

Eligibility
Key inclusion criteria
Must have taken part in the Australian Health Survey 2014-2015. Complete data from; demographic, mental health condition information, dietary intake, physical activity frequency, BMI, household information.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Missing mental health condition information

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The dependent variable is presence of an anxiety condition. Logistic regression models will be used to assess the associations with lifestyle behaviours (fruit and vegetable consumption, physical activity frequency, sedentary behaviour, weight status) and demographic (age, sex, socio-economic status, income) with presence of anxiety condition. Further models will be run to examine the age-specific and sex-specific trends of anxiety prevalence in the Australian population. All analyses will be weighted to reflect the Australian population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
1/03/2019
Actual
Date of last data collection
Anticipated
1/03/2019
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301891 0
Charities/Societies/Foundations
Name [1] 301891 0
Australian Rotary Health
Country [1] 301891 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University, Health and Education Building, 285 Ryrie Street Geelong 3220 VIC, Australia
Country
Australia
Secondary sponsor category [1] 301645 0
None
Name [1] 301645 0
Address [1] 301645 0
Country [1] 301645 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 302581 0
Ethics committee address [1] 302581 0
Ethics committee country [1] 302581 0
Date submitted for ethics approval [1] 302581 0
Approval date [1] 302581 0
Ethics approval number [1] 302581 0

Summary
Brief summary
The purpose of this study is to examine the lifestyle behavioural associations with mental health conditions, in particular anxiety, in the Australian population. We hypothesise that significant differences will be observed between individuals with anxiety, compared to depressed individuals and the general population.
Trial website
Trial related presentations / publications
Public notes
Original ethics approval is held by Australian Bureau of Statistics. Further ethical approval is not needed for analysis as data are pre-existing and non-identifiable.

Contacts
Principal investigator
Name 90714 0
Dr Erin Hoare
Address 90714 0
Food & Mood Centre, Deakin University, Ryrie Street, Geelong Victoria 3220
Country 90714 0
Australia
Phone 90714 0
+61 3 524 79383
Fax 90714 0
Email 90714 0
[email protected]
Contact person for public queries
Name 90715 0
Erin Hoare
Address 90715 0
Food & Mood Centre, Deakin University, Ryrie Street, Geelong Victoria, 3220
Country 90715 0
Australia
Phone 90715 0
+61 3 524 79383
Fax 90715 0
Email 90715 0
[email protected]
Contact person for scientific queries
Name 90716 0
Erin Hoare
Address 90716 0
Food & Mood Centre, Deakin University, Ryrie Street, Geelong Victoria 3220
Country 90716 0
Australia
Phone 90716 0
+61 3 524 79383
Fax 90716 0
Email 90716 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
Ownership lies with data custodians Australian Bureau of Statistics


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.