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A Trial to Determine the Effects of a Behavioural Communication Strategy on Salt Levels in Foods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373423
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
The George Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Reducing Salt in the Food Supply Other: Advocacy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Protocol for a Cluster-randomized Trial to Determine the Effects of a Behavioural Communication Strategy on the Salt Levels of Processed Foods
Study Start Date : December 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Advocacy program
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.
Other: Advocacy
See above for description

No Intervention: Control
No intervention program



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 and type of publicly available statements from food companies expressing support / non-support for healthier processed foods as measured by a count of statements.

  2. The number of food companies with a nutrition policy published on their website, as measured by a count [ Time Frame: 18 months ]
    The number of food companies with a nutrition policy published on their website, as measured by a count

  3. 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 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.

  4. 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 the use of salt replacers / technologies in food processing to reduce the quantity of sodium required in processing, as measured by a questionnaire

  5. 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 supporting national salt reduction initiatives as measured by a count of public pledges

  6. 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 ]
    The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction


Other Outcome Measures:
  1. Exploratory outcome: change in average saturated fat as measured by grams per 100g of product [ Time Frame: 2 years ]
    Exploratory outcome: change in average saturated fat as measured by grams per 100g of product

  2. Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product [ Time Frame: 2 years ]
    Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product

  3. Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product [ Time Frame: 2 years ]
    Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

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): NCT02373423


Sponsors and Collaborators
The George Institute
Investigators
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Principal Investigator: Bruce Neal, PhD The George Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT02373423    
Other Study ID Numbers: BN_HT1
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017