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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02105727
Registration number
NCT02105727
Ethics application status
Date submitted
30/03/2014
Date registered
7/04/2014
Date last updated
18/11/2014
Titles & IDs
Public title
Changing Population Salt Consumption in Lithgow, Australia
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Scientific title
A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
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Secondary ID [1]
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2014079
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Blood Pressure
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Hypertension
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Cardiovascular Disease
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Salt reduction - Community-based salt reduction
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Urinary sodium excretion (mmol/l)
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Assessment method [1]
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A single 24-hour urine collection will be obtained with the first voided urine upon waking on the day of collection being discarded and participants then collecting all voided urine up to and including the first void the following morning. The times at the beginning and the end of urine collection are recorded.
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Timepoint [1]
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up to 4 years
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Secondary outcome [1]
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Sources of sodium
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Assessment method [1]
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The multiple pass 24-hour dietary recall is used to determine all food and beverages consumed from midnight to midnight on the day before the interview, this method has been described in detail by prior reports. Food model booklets are used to assist with the reporting of quantity and prompts provided by interviewers are used to probe for complete food descriptions, variable recipe ingredients, and food preparation including salt added during cooking and at the table. Dietary data are entered into the nutrient analysis package FoodWorks Professional version 7. The food coding guidelines are used to code each food and beverage into major, sub-major and minor food categories.
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Timepoint [1]
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up to 4 years
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Secondary outcome [2]
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Knowledge, attitudes and behaviors towards salt intake
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Assessment method [2]
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The measurement of knowledge attitude and behaviors towards salt is based upon a questionnaire adapted from the World Health Organization/Pan American Health Organization protocol for population level sodium determination. The questionnaire contains nine questions; four related to knowledge of personal consumption, recommended daily intake and possible harmful effects of salt and five assessing attitudes and behaviors to lowering salt intake.
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Timepoint [2]
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up to 4 years
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Eligibility
Key inclusion criteria
* All adults over the age of 20 years residing in the Lithgow area are eligible
* No exclusion based on inter-current illness, use of medications or any other aspect of demography or personal history.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2014
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Sample size
Target
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Accrual to date
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Final
991
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute for Global Health - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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New South Wales Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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New South Wales Food Authority
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Australian Food and Grocery Council
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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National Health and Medical Research Council, Australia
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to determine whether a community-based salt reduction program can reduce average salt consumption levels. Baseline levels of salt consumption were measured in 2011, the salt reduction program was then implemented, and now in 2014 investigators are remeasuring salt consumption levels in the community. The hypothesis investigators are testing is that the salt reduction program will have led to a change in salt consumption levels between 2011 and 2014. The study is being done in Lithgow, a regional town in New South Wales , Australia.
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Trial website
https://clinicaltrials.gov/study/NCT02105727
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Trial related presentations / publications
Land MA, Webster J, Christoforou A, Johnson C, Trevena H, Hodgins F, Chalmers J, Woodward M, Barzi F, Smith W, Flood V, Jeffery P, Nowson C, Neal B. The association of knowledge, attitudes and behaviours related to salt with 24-hour urinary sodium excretion. Int J Behav Nutr Phys Act. 2014 Apr 4;11(1):47. doi: 10.1186/1479-5868-11-47. Land MA, Webster J, Christoforou A, Praveen D, Jeffery P, Chalmers J, Smith W, Woodward M, Barzi F, Nowson C, Flood V, Neal B. Salt intake assessed by 24 h urinary sodium excretion in a random and opportunistic sample in Australia. BMJ Open. 2014 Jan 16;4(1):e003720. doi: 10.1136/bmjopen-2013-003720. Land MA, Jeffery P, Webster J, Crino M, Chalmers J, Woodward M, Nowson C, Smith W, Flood V, Neal B. Protocol for the implementation and evaluation of a community-based intervention seeking to reduce dietary salt intake in Lithgow, Australia. BMC Public Health. 2014 Apr 14;14:357. doi: 10.1186/1471-2458-14-357. Land MA, Wu JH, Selwyn A, Crino M, Woodward M, Chalmers J, Webster J, Nowson C, Jeffery P, Smith W, Flood V, Neal B. Effects of a community-based salt reduction program in a regional Australian population. BMC Public Health. 2016 May 11;16:388. doi: 10.1186/s12889-016-3064-3.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
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
Type
Citations or Other Details
Journal
Land MA, Webster J, Christoforou A, Praveen D, Jef...
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More Details
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Journal
Land MA, Jeffery P, Webster J, Crino M, Chalmers J...
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More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT02105727
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