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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
Secondary ID [1] 0 0
2014079
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 0 0
Hypertension 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Community-based salt reduction

Experimental: Salt reduction - Community-based salt reduction


Behaviour: Community-based salt reduction


Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinary sodium excretion (mmol/l) - 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.
Timepoint [1] 0 0
up to 4 years
Secondary outcome [1] 0 0
Sources of sodium - 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.
Timepoint [1] 0 0
up to 4 years
Secondary outcome [2] 0 0
Knowledge, attitudes and behaviors towards salt intake - 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.
Timepoint [2] 0 0
up to 4 years

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.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
New South Wales Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
New South Wales Food Authority
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian Food and Grocery Council
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National Health and Medical Research Council, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02105727
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications