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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Control
No intervention program
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean sodium content change as measured by sodium content (mg) per 100g of food product
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 2 years
|
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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bruce Neal, PhD, The George Institute
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- BN_HT1
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Ensayos clínicos sobre Advocacy
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University of South CarolinaWayne State University; Henan UniversityTerminadoAjuste emocional | Sida/Problema del VIHEstados Unidos