Blood PressureNCT02105727
Changing Population Salt Consumption in Lithgow, Australia
A study testing Community-based salt reduction in people with Blood Pressure and Hypertension, run by The George Institute at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension, Cardiovascular Disease
- What is being tested?
- Community-based salt reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 991 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The George Institute for Global Health
Camperdown, New South Wales, 2050
About this study
Official title: A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done 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.
Read the 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.
- Conditions
- Blood Pressure, Hypertension, Cardiovascular Disease
- Being tested
- Community-based salt reduction
- Keywords
- Dietary sodium, Urinary sodium excretion, Urinary iodine excretion
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based salt reductionBehavioural
Also called Salt-substitute, Education, Smartphone application - FoodSwitch/Saltswitch
| Study group | Role | What they receive |
|---|---|---|
| Salt reduction | Experimental | Community-based salt reduction Receives: Behavioral: Community-based salt reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 991 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- New South Wales Health, New South Wales Food Authority, Australian Food and Grocery Council, National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Professor Bruce Neal, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105727
- Sponsor's protocol ID
- 2014079
- Status last verified
- Nov 2014
- First submitted
- 30 Mar 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24708561Land 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(1):e003720. doi: 10.1136/bmjopen-2013-003720.
PubMed 24440795Land 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 Health. 2014 Apr 14;14:357. doi: 10.1186/1471-2458-14-357.
PubMed 24731226Land MA, Wu JH, Selwyn A, Crino M, Woodward M, Chalmers J, Webster J, Nowson C, Jeffery P, Smith W, Flood V, Neal B. Effects of a community-based salt reduction program in a regional Australian population. BMC Public Health. 2016 May 11;16:388. doi: 10.1186/s12889-016-3064-3.
PubMed 27169380
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
- ClinicalTrials.gov ID
- NCT02105727
- Acronym / sponsor ID
- 2014079
- Conditions
- Blood Pressure, Hypertension, Cardiovascular Disease
- Keywords
- Dietary sodium, Urinary sodium excretion, Urinary iodine excretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 991 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- New South Wales Health, New South Wales Food Authority, Australian Food and Grocery Council, National Health and Medical Research Council, Australia
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salt reduction | Experimental | Behavioral: Community-based salt reductionCommunity-based salt reduction |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based salt reductionAlso: Salt-substitute, Education, Smartphone application - FoodSwitch/Saltswitch | Behavioural | Salt reduction |
Primary outcome
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.
2 secondary outcomes
Sources of sodium
Time frame: up to 4 years
Knowledge, attitudes and behaviors towards salt intake
Time frame: up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Background: PubMed 24708561Land 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.
- Results publication: PubMed 24440795Land 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(1):e003720. doi: 10.1136/bmjopen-2013-003720.
- Results publication: PubMed 24731226Land 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 Health. 2014 Apr 14;14:357. doi: 10.1186/1471-2458-14-357.
- Derived from this study: PubMed 27169380Land MA, Wu JH, Selwyn A, Crino M, Woodward M, Chalmers J, Webster J, Nowson C, Jeffery P, Smith W, Flood V, Neal B. Effects of a community-based salt reduction program in a regional Australian population. BMC Public Health. 2016 May 11;16:388. doi: 10.1186/s12889-016-3064-3.
Related trials for Blood Pressure
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based salt reduction in people with Blood Pressure and Hypertension, run by The George Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary sodium excretion (mmol/l) (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105727, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.