Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001142729
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Date results provided
22/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of two behaviour change techniques designed to optimise safe food-handling among consumers
Scientific title
Evaluating the effectiveness of two behaviour change techniques designed to optimise safe food-handling among consumers
Secondary ID [1] 307779 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
food poisoning 327358 0
Condition category
Condition code
Public Health 324483 324483 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants were recruited online in Australia. Participants clicked a link to the survey via advertising materials placed online. The link directed participants to an online survey which assessed baseline measures immediately prior to the intervention, with these baseline measures again administered two weeks later. All measures and intervention materials were administered via an online survey. The first survey containing the intervention was anticipated to take approximately 30 minutes to complete, and the second follow-up survey was anticipated to take 15 minutes to complete.

As part of the intervention, participants first watched two informational food safety videos from the 'Play it Food Safe' campaign from the Western Australian Department of Health. One video was on safe cooking behaviour (link: https://www.youtube.com/watch?v=eKy_eto2f-4) and one video was on safe chilling behaviour (link: https://www.youtube.com/watch?v=i-HlZOOWjFI). After watching both videos, participants were then randomly allocated (by the survey software, Qualtrics) to one of two conditions to determine which may change four target safe food handling behaviours, which were: (1) reheating food until it is steaming hot, (2) cooking eggs until the yolks and whites are firm, (3) using a cooler bag when shopping for groceries, (4) freezing and/or refrigerating perishable foods as soon as possible after purchasing.

The first intervention condition was the 'risk intervention group' where participants completed an anticipated regret task. In this task, participants had to write anticipated regret statements by indicating the consequence of not performing four target behaviours. Participants were provided with the start of the statement to then complete for each target behaviour (e.g., "If I do not reheat food until it is steaming hot...". Participants indicated an anticipated regret statement for each of the four target behaviours listed above.

The second intervention condition was the 'habit intervention group' who were required to formulate an implementation intention. This involved developing 'If, then' plans for each behaviour. Participants were provided with an example not relevant to food safety or the target behaviours, instead relevant to reducing sugary drink consumption (i.e., "“If I go out for lunch with friends, then I will drink water instead of soft drink.”). Participants formulated an 'if, then' plan for each target behaviour, and were provided with tips or prompts to help them think of the plan for each behaviour (e.g., for reheating food until it is steaming hot "Tip: Think about where you reheat food the most, for example, at work or home?").

To ensure the measures and interventions were completed, data was checked in the survey software (Qualtrics) for completion rates.
Intervention code [1] 324244 0
Behaviour
Comparator / control treatment
No control group was used. Instead, two active conditions were compared at the same time as per the above description of the intervention. However the risk group described above was compared to the habit group described below.

The second intervention condition was the 'habit intervention group' who were required to formulate an implementation intention. This involved developing 'If, then' plans for each behaviour. Participants were provided with an example not relevant to food safety or the target behaviours, instead relevant to reducing sugary drink consumption (i.e., "“If I go out for lunch with friends, then I will drink water instead of soft drink.”). Participants formulated an 'if, then' plan for each target behaviour, and were provided with tips or prompts to help them think of the plan for each behaviour (e.g., for reheating food until it is steaming hot "Tip: Think about where you reheat food the most, for example, at work or home?").
Control group
Active

Outcomes
Primary outcome [1] 332306 0
Behaviour 1 - using a cooler bag when shopping for groceries: Participants were asked how often they performed this behaviour using a five-point Likert scale ranging from 0 (never) to 4 (always) to indicate how often they engaged in the safe food-handling behaviour.
Timepoint [1] 332306 0
Baseline, two-weeks following intervention.
Primary outcome [2] 332348 0
Behaviour 2 - freezing and refrigerating food as soon as possible after purchasing: Participants were asked how often they performed this behaviour using a five-point Likert scale ranging from 0 (never) to 4 (always) to indicate how often they engaged in the safe food-handling behaviour.
Timepoint [2] 332348 0
Baseline, two-weeks following intervention.
Primary outcome [3] 332349 0
Behaviour 3 - reheating food until it is steaming hot throughout: Participants were asked how often they performed this behaviour using a five-point Likert scale ranging from 0 (never) to 4 (always) to indicate how often they engaged in the safe food-handling behaviour.
Timepoint [3] 332349 0
Baseline, two-weeks following intervention.
Secondary outcome [1] 412926 0
Behaviour 4 - cooking eggs until the yolks and whites are firm: Participants were asked how often they performed this behaviour using a five-point Likert scale ranging from 0 (never) to 4 (always) to indicate how often they engaged in the safe food-handling behaviour.
Timepoint [1] 412926 0
Baseline, two-weeks following intervention.
Secondary outcome [2] 412929 0
Perceived risk for behaviour 1 (using a cooler bag when shopping for groceries): Participants were also asked to estimate the likelihood that they will suffer from food poisoning, compared to other people their age and gender, if they did not use a cooler bag when shopping for groceries. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Participants were also asked to estimate the likelihood that someone in their household will suffer from food poisoning, compared to other people their age and gender, if they do not use a cooler bag when shopping for groceries. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely).

Participants were asked how severe they thought food poisoning would be for them and for someone in their household. This was rated on a five-point Likert scale ranging from 1 (not at all severe) to 5 (extremely severe). These scores were combined with the risk score above.
Timepoint [2] 412929 0
Baseline, two-weeks following intervention.
Secondary outcome [3] 413043 0
Perceived risk for behaviour 2 (freezing and refrigerating food as soon as possible after purchasing): Participants were also asked to estimate the likelihood that they will suffer from food poisoning, compared to other people their age and gender, if they did not freeze and refrigerate food as soon as possible after purchasing. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Participants were also asked to estimate the likelihood that someone in their household will suffer from food poisoning, compared to other people their age and gender, if they do not freeze and refrigerate food as soon as possible after purchasing. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely).

Participants were asked how severe they thought food poisoning would be for them and for someone in their household. This was rated on a five-point Likert scale ranging from 1 (not at all severe) to 5 (extremely severe). These scores were combined with the risk score above.
Timepoint [3] 413043 0
Baseline, two-weeks following intervention.
Secondary outcome [4] 413135 0
Perceived risk for behaviour 3 (reheating food until it is steaming hot throughout): Participants were also asked to estimate the likelihood that they will suffer from food poisoning, compared to other people their age and gender, if they did not reheat food until it is steaming hot throughout. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Participants were also asked to estimate the likelihood that someone in their household will suffer from food poisoning, compared to other people their age and gender, if they do not reheat food until it is steaming hot throughout. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely).

Participants were asked how severe they thought food poisoning would be for them and for someone in their household. This was rated on a five-point Likert scale ranging from 1 (not at all severe) to 5 (extremely severe). These scores were combined with the risk score above.
Timepoint [4] 413135 0
Baseline, two-weeks following intervention.
Secondary outcome [5] 413136 0
Perceived risk for behaviour 4 (cooking eggs until the yolks and whites are firm): Participants were also asked to estimate the likelihood that they will suffer from food poisoning, compared to other people their age and gender, if they did not cooking eggs until the yolks and whites are firm. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Participants were also asked to estimate the likelihood that someone in their household will suffer from food poisoning, compared to other people their age and gender, if they do not cooking eggs until the yolks and whites are firm. This was rated on a seven-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely).

Participants were asked how severe they thought food poisoning would be for them and for someone in their household. This was rated on a five-point Likert scale ranging from 1 (not at all severe) to 5 (extremely severe). These scores were combined with the risk score above.
Timepoint [5] 413136 0
Baseline, two-weeks following intervention.
Secondary outcome [6] 413137 0
Habit for behaviour 1 (using a cooler bag when shopping for groceries): The self-report behavioural automaticity index was used to measure habit for using a cooler bag when shopping for groceries.
Timepoint [6] 413137 0
Baseline, two-weeks following intervention.
Secondary outcome [7] 413138 0
Habit for behaviour 2 (freezing and refrigerating food as soon as possible after purchasing): The self-report behavioural automaticity index was used to measure habit for freezing and refrigerating food as soon as possible after purchasing.
Timepoint [7] 413138 0
Baseline, two-weeks following intervention.
Secondary outcome [8] 413139 0
Habit for behaviour 3 (reheating food until it is steaming hot throughout): The self-report behavioural automaticity index was used to measure habit for reheating food until it is steaming hot throughout.
Timepoint [8] 413139 0
Baseline, two-weeks following intervention.
Secondary outcome [9] 413140 0
Habit for behaviour 4 (cooking eggs until the yolks and whites are firm): The self-report behavioural automaticity index was used to measure habit for cooking eggs until the yolks and whites are firm.
Timepoint [9] 413140 0
Baseline, two-weeks following intervention.
Secondary outcome [10] 413141 0
Knowledge - safe food-handling knowledge in relation to each target safe food-handling behaviour was assessed using multiple choice questions. These questions were taken from the safe food-handling knowledge questionnaire developed by Charlesworth et al. (2022).
Timepoint [10] 413141 0
Baseline, two-weeks following intervention.

Eligibility
Key inclusion criteria
Participants had to reside in Australia. They also had to cook and/or prepare food at home (including eggs), and shop for groceries for their household.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants had to be over 13 years of age to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to either condition was determined randomly by the survey software (Qualtrics). Allocation to either condition was concealed by central randomisation by survey software (Qualtrics).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to either condition was determined randomly by the survey software (Qualtrics).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis was conducted prior to data collection to determine the anticipated sample size.

A series of mixed between-within participants analyses of variance were conducted to determine change in behaviour, habit, and risk for each target safe food-handling behaviour over time among both intervention groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/06/2021
Date of last participant enrolment
Anticipated
Actual
26/10/2021
Date of last data collection
Anticipated
Actual
4/11/2021
Sample size
Target
88
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312051 0
University
Name [1] 312051 0
Curtin University
Country [1] 312051 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, WA, 6102
Country
Australia
Secondary sponsor category [1] 313554 0
None
Name [1] 313554 0
Address [1] 313554 0
Country [1] 313554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311463 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 311463 0
Ethics committee country [1] 311463 0
Australia
Date submitted for ethics approval [1] 311463 0
27/04/2021
Approval date [1] 311463 0
04/05/2021
Ethics approval number [1] 311463 0
HRE2020-0186-04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121182 0
Prof Barbara Mullan
Address 121182 0
Curtin University, Kent Street, Bentley, WA, 6102
Country 121182 0
Australia
Phone 121182 0
+61 08 9266 2468
Fax 121182 0
Email 121182 0
[email protected]
Contact person for public queries
Name 121183 0
Barbara Mullan
Address 121183 0
Curtin University, Kent Street, Bentley, WA, 6102
Country 121183 0
Australia
Phone 121183 0
+61 08 9266 2468
Fax 121183 0
Email 121183 0
[email protected]
Contact person for scientific queries
Name 121184 0
Barbara Mullan
Address 121184 0
Curtin University, Kent Street, Bentley, WA, 6102
Country 121184 0
Australia
Phone 121184 0
+61 08 9266 2468
Fax 121184 0
Email 121184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not indicated in ethics application.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.