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

2 mei 2017 bijgewerkt door: The George Institute

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

45

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Advocacy
See above for description
Geen tussenkomst: Control
No intervention program

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Tijdsspanne: Two years
Mean sodium content change as measured by sodium content (mg) per 100g of food
Two years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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.
18 months
The number of food companies with a nutrition policy published on their website, as measured by a count
Tijdsspanne: 18 months
The number of food companies with a nutrition policy published on their website, as measured by a count
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
Tijdsspanne: 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.
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
Tijdsspanne: 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
18 months
The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
Tijdsspanne: 18 months
The number of companies supporting national salt reduction initiatives as measured by a count of public pledges
18 months
The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
Tijdsspanne: 18 months
The number of companies providing evidence of planned salt reduction as measured by a count of the plans / commitments to salt reduction
18 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Tijdsspanne: 2 years
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
2 years
Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product
Tijdsspanne: 2 years
Exploratory outcome: change in average sugars content as measured by grams of sugar per 100g of product
2 years
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
Tijdsspanne: 2 years
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The George Institute

Onderzoekers

  • Hoofdonderzoeker: Bruce Neal, PhD, The George Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2013

Primaire voltooiing (Werkelijk)

1 juni 2016

Studie voltooiing (Werkelijk)

1 juni 2016

Studieregistratiedata

Eerst ingediend

8 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

22 februari 2015

Eerst geplaatst (Schatting)

27 februari 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2017

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • BN_HT1

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