Clinical trial NCT02105727: Changing Population Salt Consumption in Lithgow, Australia
Official title: A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Cardiovascular Disease
Keywords: Dietary sodium
Urinary sodium excretion
Urinary iodine excretion
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: New South Wales Health
name: New South Wales Food Authority
name: Australian Food and Grocery Council
name: National Health and Medical Research Council, Australia
First posted: 2014-04-07
Enrollment: 991
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this project is to determine whether there have been changes in average salt consumption levels in the Lithgow population from 2011 to 2014. The primary null hypothesis to be tested is that there will be no difference between the mean 24-hour urinary sodium excretion levels between 2011 and 2014.

The sample of 419 individuals with 24-hour urine samples in the baseline survey and 600 individuals in the follow-up survey will provide 80% power to detect a difference of 0.7 g/day salt between the mean levels of excretion before and after the intervention. There will be more than 95% power to detect a difference of 1.0 g/day salt or greater.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary sodium excretion (mmol/l)
timeFrame: up to 4 years
Secondary outcomes:
measure: Sources of sodium
timeFrame: up to 4 years
measure: Knowledge, attitudes and behaviors towards salt intake
timeFrame: up to 4 years
Other outcomes:
measure: Urinary iodine excretion (ug/l)
timeFrame: up to 4 years
Locations:
city: Camperdown
country: Australia
facility: The George Institute for Global Health
state: New South Wales
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.