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Changing Population Salt Consumption in Lithgow, Australia

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ClinicalTrials.gov Identifier: NCT02105727
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : November 18, 2014
Sponsor:
Collaborators:
New South Wales Health
New South Wales Food Authority
Australian Food and Grocery Council
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Professor Bruce Neal, The George Institute

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Cardiovascular Disease Behavioral: Community-based salt reduction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 991 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
Study Start Date : March 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Salt reduction
Community-based salt reduction
Behavioral: Community-based salt reduction
Other Names:
  • Salt-substitute
  • Education
  • Smartphone application - FoodSwitch/Saltswitch




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105727


Locations
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Australia, New South Wales
The George Institute for Global Health
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
The George Institute
New South Wales Health
New South Wales Food Authority
Australian Food and Grocery Council
National Health and Medical Research Council, Australia

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Bruce Neal, Professor, The George Institute
ClinicalTrials.gov Identifier: NCT02105727     History of Changes
Other Study ID Numbers: 2014079
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Professor Bruce Neal, The George Institute:
Dietary sodium
Urinary sodium excretion
Urinary iodine excretion
Additional relevant MeSH terms:
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Cardiovascular Diseases