Changing Population Salt Consumption in Lithgow, Australia

Hypertension Clinical Trial

Official title:

A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105727
• Other study ID #: 2014079
• Status: Completed
• Phase: N/A
• First received: March 30, 2014
• Last updated: November 17, 2014
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2014
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 991
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Community-based salt reduction

Locations

Country	Name	City	State
Australia	The George Institute for Global Health	Camperdown	New South Wales

Sponsors (5)

Lead Sponsor	Collaborator
The George Institute	Australian Food and Grocery Council, National Health and Medical Research Council, Australia, New South Wales Food Authority, New South Wales Health

Country where clinical trial is conducted

Australia, 

References & Publications (3)

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 He — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary iodine excretion (ug/l)	UIE will be assessed in the spot urine samples of females aged 20-45 years old. The measurement will be completed by using ammonium persulfate digestion prior to Sandell-Koltoff reaction in a microtitre plate format.	up to 4 years	No
Primary	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.	up to 4 years	No
Secondary	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.	up to 4 years	No
Secondary	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.	up to 4 years	No