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

2017年5月2日 更新者: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.

研究概览

地位

完全的

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

45

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
无干预:Control
No intervention program

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean sodium content change as measured by sodium content (mg) per 100g of food product
大体时间:Two years
Mean sodium content change as measured by sodium content (mg) per 100g of food
Two years

次要结果测量

结果测量
措施说明
大体时间
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.
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
大体时间: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
大体时间: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
大体时间:2 years
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bruce Neal, PhD、The George Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年12月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2015年2月8日

首先提交符合 QC 标准的

2015年2月22日

首次发布 (估计)

2015年2月27日

研究记录更新

最后更新发布 (实际的)

2017年5月4日

上次提交的符合 QC 标准的更新

2017年5月2日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • BN_HT1

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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