NCT02105727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
991

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

March 30, 2014

Last Update Submit

November 17, 2014

Conditions

Blood PressureHypertensionCardiovascular Disease

Keywords

Dietary sodiumUrinary sodium excretionUrinary iodine excretion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sources of sodium

    up to 4 years

  • Knowledge, attitudes and behaviors towards salt intake

    up to 4 years

Other Outcomes (1)

  • Urinary iodine excretion (ug/l)

    up to 4 years

Study Arms (1)

Salt reduction

EXPERIMENTAL

Community-based salt reduction

Behavioral: Community-based salt reduction

Interventions

Community-based salt reductionBEHAVIORAL
Also known as: Salt-substitute, Education, Smartphone application - FoodSwitch/Saltswitch
Salt reduction

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults over the age of 20 years residing in the Lithgow area are eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Institute for Global Health

Camperdown, New South Wales, 2050, Australia

Location

Related Publications (4)

  • 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.

    PMID: 24708561BACKGROUND

  • Land 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.

    PMID: 24440795RESULT

  • Land 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.

    PMID: 24731226RESULT

  • Land 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.

    PMID: 27169380DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 7, 2014

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

AU(1)