Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000528358
Ethics application status
Approved
Date submitted
4/08/2008
Date registered
15/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Achieving the salt intake target of 6g / day in the current food supply using two dietary education strategies
Scientific title
Achieving the salt intake target of 6g / day in the current food supply among freeliving adults using two dietary education strategies
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participants ability to adhere to a dietary strategy for reducing sodium intake 3502 0
Condition category
Condition code
Diet and Nutrition 3657 3657 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in group 1 will be required to follow a low salt diet (ie replace usual food choices with those that have <120mg of sodium per 100g). Basic advice to be provided at baseline via 15 min group session. A 15 min follow-up session to reiterate instructions held 5 weeks later. No food is supplied
Intervention code [1] 3224 0
Lifestyle
Comparator / control treatment
Participants in the other group will be required to follow the National Heart Foundation 'tick' program (ie replace usual food choices with those which have the National Heart Foundation 'Tick'). Basic advice to be provided at baseline via 15 min group session. A 15 min follow-up session to reiterate instructions held 5 weeks later. No food is supplied
Control group
Active

Outcomes
Primary outcome [1] 4561 0
Urinary Sodium Excretion
Timepoint [1] 4561 0
Baseline, Week 4, Week 8
Secondary outcome [1] 7712 0
Urinary Potassium Excretion
Timepoint [1] 7712 0
Baseline, Week 4, Week 8
Secondary outcome [2] 7713 0
Blood Pressure
Timepoint [2] 7713 0
Baseline, Week 4, Week 8
Secondary outcome [3] 7714 0
Weight
Timepoint [3] 7714 0
Baseline, Week 4, Week 8
Secondary outcome [4] 7715 0
Urinary Creatinine Excretion
Timepoint [4] 7715 0
Baseline, Week 4, Week 8

Eligibility
Key inclusion criteria
Free Living - participants must be capable of making their own choices with regard to food purchasing and preparation
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Metabolic Diseases - ie Liver / Kidney Disease
Cardiovascular Disease
Hypertension (systolic >160mmHg)
Taking Diuretics

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3676 0
Government body
Name [1] 3676 0
The Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Country [1] 3676 0
Australia
Primary sponsor type
Government body
Name
The Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address
Gate 13 Kintore Ave, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 3301 0
None
Name [1] 3301 0
Address [1] 3301 0
Country [1] 3301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5730 0
CSIRO Human Nutrition - Human Research Ethics Committee
Ethics committee address [1] 5730 0
Ethics committee country [1] 5730 0
Australia
Date submitted for ethics approval [1] 5730 0
Approval date [1] 5730 0
20/06/2008
Ethics approval number [1] 5730 0
08/01

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

Contacts
Principal investigator
Name 28806 0
Address 28806 0
Country 28806 0
Phone 28806 0
Fax 28806 0
Email 28806 0
Contact person for public queries
Name 11963 0
Dr Jennifer Keogh
Address 11963 0
CSIRO - Gate 13 Kintore Ave, Adelaide, SA 5000
Country 11963 0
Australia
Phone 11963 0
08 8303 8907
Fax 11963 0
Email 11963 0
[email protected]
Contact person for scientific queries
Name 2891 0
Dr Jennifer Keogh
Address 2891 0
CSIRO - Gate 13 Kintore Ave, Adelaide, SA 5000
Country 2891 0
Australia
Phone 2891 0
08 8303 8907
Fax 2891 0
Email 2891 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.