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
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Hypertension Cardiovascular Disease||Behavioral: Community-based salt reduction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||991 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Salt reduction
Community-based salt reduction
Behavioral: Community-based salt reduction
- 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.
- 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.
- 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.
- 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.
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
|Australia, New South Wales|
|The George Institute for Global Health|
|Camperdown, New South Wales, Australia, 2050|