A Trial to Determine the Effects of a Behavioural Communication Strategy on Salt Levels in Foods
Protocol for a Cluster-randomized Trial to Determine the Effects of a Behavioural Communication Strategy on the Salt Levels of Processed Foods
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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See above for description
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Žádný zásah: Control
No intervention program
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean sodium content change as measured by sodium content (mg) per 100g of food product
Časové okno: Two years
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Mean sodium content change as measured by sodium content (mg) per 100g of food
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Two years
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 18 months
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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.
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18 months
|
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The number of food companies with a nutrition policy published on their website, as measured by a count
Časové okno: 18 months
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The number of food companies with a nutrition policy published on their website, as measured by a count
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18 months
|
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The level of engagement with the non-government organization, as measured by a count of pre-defined methods of communication from the food company
Časové okno: 18 months
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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.
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18 months
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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
Časové okno: 18 months
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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
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18 months
|
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The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
Časové okno: 18 months
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The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
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18 months
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The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
Časové okno: 18 months
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The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
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18 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Časové okno: 2 years
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Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
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2 years
|
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Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product
Časové okno: 2 years
|
Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product
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2 years
|
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Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
Časové okno: 2 years
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Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
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2 years
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Bruce Neal, PhD, The George Institute
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- BN_HT1
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