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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
介入なし：Control
No intervention program
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean sodium content change as measured by sodium content (mg) per 100g of food product
時間枠：Two years
|
Mean sodium content change as measured by sodium content (mg) per 100g of food
|
Two years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory outcome: change in average saturated fat as measured by grams per 100g of product
時間枠：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
時間枠：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
時間枠：2 years
|
Exploratory outcome: change in average energy density content as measured by kilojoules (kJ) per 100g of product
|
2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Bruce Neal, PhD、The George Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BN_HT1
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。