Changing Population Salt Consumption in Lithgow, Australia

Study Overview
=================
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.

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

Conditions
-----------------
Blood Pressure, Hypertension, Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Community-based salt reduction


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salt reduction<br>Community-based salt reduction | Behavioral: Community-based salt reduction<br> <br> * Other names: Smartphone application - FoodSwitch/Saltswitch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary sodium, Urinary sodium excretion, Urinary iodine excretion