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

2 maggio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Advocacy
See above for description
Nessun intervento: Control
No intervention program

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Lasso di tempo: Two years
Mean sodium content change as measured by sodium content (mg) per 100g of food
Two years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 2 years
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The George Institute

Investigatori

  • Investigatore principale: Bruce Neal, PhD, The George Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2013

Completamento primario (Effettivo)

1 giugno 2016

Completamento dello studio (Effettivo)

1 giugno 2016

Date di iscrizione allo studio

Primo inviato

8 febbraio 2015

Primo inviato che soddisfa i criteri di controllo qualità

22 febbraio 2015

Primo Inserito (Stima)

27 febbraio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • BN_HT1

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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