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

2. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
See above for description
Ingen indgriben: Control
No intervention program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Tidsramme: Two years
Mean sodium content change as measured by sodium content (mg) per 100g of food
Two years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 years
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Bruce Neal, PhD, The George Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2013

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

8. februar 2015

Først indsendt, der opfyldte QC-kriterier

22. februar 2015

Først opslået (Skøn)

27. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BN_HT1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Advocacy

3
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