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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Aucune intervention: Control
No intervention program
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Délai: Two years
|
Mean sodium content change as measured by sodium content (mg) per 100g of food
|
Two years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Délai: 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
Délai: 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
Délai: 2 years
|
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
|
2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bruce Neal, PhD, The George Institute
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BN_HT1
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