Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001260516p
Ethics application status
Submitted, not yet approved
Date submitted
5/09/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the dietary perceptions, habitual diet and diet quality of adolescents and adults with Primary Sclerosing Cholangitis
Scientific title
EvaluATing the dietary perceptions, habitual dietary intake, diet quality and adherence to population-based dietary guidelines of adolescents and adults with Primary Sclerosing Cholangitis (EAT-PSC).
Secondary ID [1] 312913 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EAT-PSC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Sclerosing Cholangitis 335074 0
Condition category
Condition code
Oral and Gastrointestinal 331580 331580 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Primary sclerosing cholangitis (PSC), is a rare autoimmune liver disease with no effective medical therapies. The aetiology and pathogenesis of PSC are unknown, however, evolving evidence suggests dysbiosis of the gut microbiota may be a contributing factor. Diet is a key fertiliser of gut microbiota and therefore has potential to be a modifiable risk factor. However, very limited data on dietary patterns and trends of people with PSC exist
This is an observational study of habitual dietary intake where participants will be asked to complete online questionnaires and a food frequency questionnaire to observe habitual dietary patterns and the dietary perceptions and food beliefs that inform dietary behaviour and food choice. This will occur at a single timepoint and the online questionnaires are expected to take 20-30 minutes to complete
Intervention code [1] 329447 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339317 0
Nutritional adequacy of habitual dietary patterns
Timepoint [1] 339317 0
One time data collection
Secondary outcome [1] 439443 0
Dietary adherence to population-based dietary guidelines
Timepoint [1] 439443 0
One time data collection
Secondary outcome [2] 439445 0
Diet quality
Timepoint [2] 439445 0
One time data collection
Secondary outcome [3] 439446 0
Composite outcome of dietary perceptions, beliefs and attitudes to dietary change
Timepoint [3] 439446 0
One time data collection

Eligibility
Key inclusion criteria
Adolescents and adults (equal to or greater than 16 years old) with a diagnosis of PSC self-confirmed via imaging and biochemical markers will be invited to participate in this study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are those unable to read and interpret English.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to analyse data collected as part of this study. Categorical data will be collected from semi-quantitative survey questions. This data will be expressed as frequency and percentage. Qualitative data collected where text responses are required will be quantitatively grouped into categories where possible and expressed as frequency and percentage.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26546 0
New Zealand
State/province [1] 26546 0
Country [2] 26547 0
United Kingdom
State/province [2] 26547 0

Funding & Sponsors
Funding source category [1] 317344 0
Charities/Societies/Foundations
Name [1] 317344 0
PSC Support Australia
Country [1] 317344 0
Australia
Funding source category [2] 317345 0
Hospital
Name [2] 317345 0
The Queen Elizabath Hospital IBD Service
Country [2] 317345 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital, Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 319630 0
None
Name [1] 319630 0
Address [1] 319630 0
Country [1] 319630 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316075 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316075 0
Ethics committee country [1] 316075 0
Australia
Date submitted for ethics approval [1] 316075 0
19/08/2024
Approval date [1] 316075 0
Ethics approval number [1] 316075 0

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

Contacts
Principal investigator
Name 136698 0
Dr Alice Day
Address 136698 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South 5011 South Australia
Country 136698 0
Australia
Phone 136698 0
+61 8 8222 8534
Fax 136698 0
Email 136698 0
[email protected]
Contact person for public queries
Name 136699 0
Alice Day
Address 136699 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South 5011 South Australia
Country 136699 0
Australia
Phone 136699 0
+61 8 8222 8534
Fax 136699 0
Email 136699 0
[email protected]
Contact person for scientific queries
Name 136700 0
Alice Day
Address 136700 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South 5011 South Australia
Country 136700 0
Australia
Phone 136700 0
+61 8 8222 8534
Fax 136700 0
Email 136700 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


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.