Reducing Salt in the Food SupplyNCT02373423
A Trial to Determine the Effects of a Behavioural Communication Strategy on Salt Levels in Foods
A study testing Advocacy in people with Reducing Salt in the Food Supply, run by The George Institute.
Trial summary
A clustered-randomized controlled trial in which 45 food companies are the unit of randomization. The intervention companies will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Reducing Salt in the Food Supply
- What is being tested?
- Advocacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The unit of randomization is a food company. Food companies were included if they had
- Australian based production, distribution or marketing of processed foods.
- 20 or more processed food items recorded in a food composition database (2011).
- the types of food they manufacturer are likely to contain added salt, sugars or saturated fats.
Who cannot join
- No identifiable Australian operation.
- Less than 20 processed food items recorded in a food composition database (2011).
- A company was known to be in receivership.
About this study
Official title: Protocol for a Cluster-randomized Trial to Determine the Effects of a Behavioural Communication Strategy on the Salt Levels of Processed Foods
A clustered-randomized controlled trial in which 45 food companies are the unit of randomization. The intervention companies will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model. The control companies will have no specific intervention targeted at them. The aim of this study is to quantify the effects of advocacy delivered by a local non-government organization on the salt content of food products produced or marketed by companies in Australia.
Read the detailed description
The product formulations of processed packaged foods frequently require added salt. Salt reduction in these foods is a focus of non-governmental organisations (NGOs) in an effort to reduce diet related disease. Evidence suggests that advocacy does have the potential to influence corporate behaviour but few robust data exist to describe the effects of NGO actions on food companies' salt reduction efforts.
A food composition database was used to select eligible food companies in Australia which were then classified into three strata based on company ownership, size of company and industry sector. Of the 45 food companies, 23 were randomised to the control group, and 22 to the intervention. The sample will provide 80% power to detect a difference of 50mg/100g in mean sodium levels assuming a mean of 430mg/100g, standard deviation of 300mg/100g and intracluster correlation coefficient (ICC) of 0.05 using a two-sided T-test with a significance level of 0.05.
The control group will have no specific intervention targeted at them but specific requests of the study team will be acted upon within the resources available. The intervention group will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model.
Data for the study will derive from periodic surveys of the characteristics of included companies, annual surveys of the composition of the processed foods they provide and an advocacy log recording all elements of the intervention program.
The study is being conducted by an Australian NGO over two years between December 2013-2015. Ethics approval to collect survey questionnaire and interview data from food companies has been obtained from the Human Research Ethics Committee at the University of Sydney.
This study will provide evidence about the potential for an Australian advocacy program to influence corporate behaviour and the quality of the processed food supply in Australia. Whether the program is effective or not the results, which use a novel experimental approach, will have important implications for the future of Australian efforts to reduce the large burden of disease caused by poor diet - a positive finding will highlight the need for investment in advocacy whilst a negative result will reinforce the importance of other, policy-based initiatives for the improvement of the food supply.
- Conditions
- Reducing Salt in the Food Supply
- Being tested
- Advocacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvocacyOther
See above for description
| Study group | Role | What they receive |
|---|---|---|
| Advocacy program | Experimental | A series of commonly used advocacy actions which will incorporate a theory of change model. Each advocacy action is targeted to change organizational capability, opportunity, or motivation of food companies to reduce salt in processed packaged foods. The intervention will span 24 months from 2013-2015. Receives: Other: Advocacy |
| Control | No intervention | No intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Mean sodium content change as measured by sodium content (mg) per 100g of food
Measured: Two years
Secondary outcomes (6)
The number of and type of publicly available statements from food companies expressing support / non-support for healthier processed foods as measured by a count of statements.
The number of and type of publicly available statements from food companies expressing support / non-support for healthier processed foods as measured by a count of statements.
Measured: 18 months
The number of food companies with a nutrition policy published on their website, as measured by a count
The number of food companies with a nutrition policy published on their website, as measured by a count
Measured: 18 months
The level of engagement with the non-government organization, as measured by a count of pre-defined methods of communication from the food company
The level of engagement with the non-government organization, as measured by a count of pre-defined methods of communication from the food company. For example, email, formal meetings, presentations.
Measured: 18 months
The number of companies supporting the use of salt replacers / technologies in food processing to reduce the quantity of sodium required in processing, as measured by a questionnaire
The number of companies supporting the use of salt replacers / technologies in food processing to reduce the quantity of sodium required in processing, as measured by a questionnaire
Measured: 18 months
The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
Measured: 18 months
The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reducing Salt in the Food SupplyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Neal, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373423
- Sponsor's protocol ID
- BN_HT1
- Status last verified
- May 2017
- First submitted
- 8 Feb 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Trevena H, Thow AM, Dunford E, Wu JHY, Neal B. Protocol for a cluster-randomised trial to determine the effects of advocacy actions on the salt content of processed foods. BMC Public Health. 2016 Jan 25;16:75. doi: 10.1186/s12889-016-2743-4.
PubMed 26809561
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Cluster-randomized Trial to Determine the Effects of a Behavioural Communication Strategy on the Salt Levels of Processed Foods
- ClinicalTrials.gov ID
- NCT02373423
- Acronym / sponsor ID
- BN_HT1
- Conditions
- Reducing Salt in the Food Supply
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Feb 2015 (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.
A clustered-randomized controlled trial in which 45 food companies are the unit of randomization. The intervention companies will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model. The control companies will have no specific intervention targeted at them. The aim of this study is to quantify the effects of advocacy delivered by a local non-government organization on the salt content of food products produced or marketed by companies in Australia.
Detailed description
The product formulations of processed packaged foods frequently require added salt. Salt reduction in these foods is a focus of non-governmental organisations (NGOs) in an effort to reduce diet related disease. Evidence suggests that advocacy does have the potential to influence corporate behaviour but few robust data exist to describe the effects of NGO actions on food companies' salt reduction efforts.
A food composition database was used to select eligible food companies in Australia which were then classified into three strata based on company ownership, size of company and industry sector. Of the 45 food companies, 23 were randomised to the control group, and 22 to the intervention. The sample will provide 80% power to detect a difference of 50mg/100g in mean sodium levels assuming a mean of 430mg/100g, standard deviation of 300mg/100g and intracluster correlation coefficient (ICC) of 0.05 using a two-sided T-test with a significance level of 0.05.
The control group will have no specific intervention targeted at them but specific requests of the study team will be acted upon within the resources available. The intervention group will receive an advocacy program which comprises of commonly used advocacy actions, incorporating a theory of change model.
Data for the study will derive from periodic surveys of the characteristics of included companies, annual surveys of the composition of the processed foods they provide and an advocacy log recording all elements of the intervention program.
The study is being conducted by an Australian NGO over two years between December 2013-2015. Ethics approval to collect survey questionnaire and interview data from food companies has been obtained from the Human Research Ethics Committee at the University of Sydney.
This study will provide evidence about the potential for an Australian advocacy program to influence corporate behaviour and the quality of the processed food supply in Australia. Whether the program is effective or not the results, which use a novel experimental approach, will have important implications for the future of Australian efforts to reduce the large burden of disease caused by poor diet - a positive finding will highlight the need for investment in advocacy whilst a negative result will reinforce the importance of other, policy-based initiatives for the improvement of the food supply.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advocacy program | Experimental | Other: AdvocacyA series of commonly used advocacy actions which will incorporate a theory of change model. Each advocacy action is targeted to change organizational capability, opportunity, or motivation of food companies to reduce salt in processed packaged foods. The intervention will span 24 months from 2013-2015. |
| Control | No intervention | –No intervention program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The unit of randomization is a food company. Food companies were included if they had
- Australian based production, distribution or marketing of processed foods.
- 20 or more processed food items recorded in a food composition database (2011).
- the types of food they manufacturer are likely to contain added salt, sugars or saturated fats.
Key exclusion criteria (3 listed)
- No identifiable Australian operation.
- Less than 20 processed food items recorded in a food composition database (2011).
- A company was known to be in receivership.
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 |
|---|---|---|
| AdvocacySee above for description | Other | Advocacy program |
Primary outcome
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Time frame: Two years
Mean sodium content change as measured by sodium content (mg) per 100g of food
6 secondary outcomes
The number of and type of publicly available statements from food companies expressing support / non-support for healthier processed foods as measured by a count of statements.
Time frame: 18 months
The number of food companies with a nutrition policy published on their website, as measured by a count
Time frame: 18 months
The level of engagement with the non-government organization, as measured by a count of pre-defined methods of communication from the food company
Time frame: 18 months
The number of companies supporting the use of salt replacers / technologies in food processing to reduce the quantity of sodium required in processing, as measured by a questionnaire
Time frame: 18 months
The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
Time frame: 18 months
The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
Time frame: 18 months
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 4 May 2017.
- Derived from this study: PubMed 26809561Trevena H, Thow AM, Dunford E, Wu JHY, Neal B. Protocol for a cluster-randomised trial to determine the effects of advocacy actions on the salt content of processed foods. BMC Public Health. 2016 Jan 25;16:75. doi: 10.1186/s12889-016-2743-4.
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.
Bruce Neal, PhD principal investigator
The George Institute
Questions about this trial
What is this clinical trial studying?
A study testing Advocacy in people with Reducing Salt in the Food Supply, run by The George Institute.
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 4 inclusion and 3 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean sodium content change as measured by sodium content (mg) per 100g of food product (time frame: Two 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 NCT02373423, which also lists 1 linked publication.
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 4 May 2017.