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Completed

NCT Number: NCT02105727

Changing Population Salt Consumption in Lithgow, Australia

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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Key information

Conditions

Blood Pressure Cardiovascular Disease Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Institute for Global Health

Camperdown, New South Wales, 2050, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community-based salt reduction

Behavioral

Other names: Salt-substitute, Education, Smartphone application - FoodSwitch/Saltswitch

Primary outcomes

  1. Urinary sodium excretion (mmol/l)

    Time frame: up to 4 years

    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.

Secondary outcomes

  1. Sources of sodium

    Time frame: up to 4 years

    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.

  2. Knowledge, attitudes and behaviors towards salt intake

    Time frame: up to 4 years

    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.

Other outcomes

  1. Urinary iodine excretion (ug/l)

    Time frame: up to 4 years

    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.

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Australian Food and Grocery Council
  • National Health and Medical Research Council, Australia
  • New South Wales Food Authority
  • New South Wales Health

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2014
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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