Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001202156
Ethics application status
Approved
Date submitted
7/08/2019
Date registered
28/08/2019
Date last updated
10/12/2020
Date data sharing statement initially provided
28/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the diet quality: "My Nutrition Score" of Australian adults using a brief, online, tailored, nutrition messaging intervention: A Randomised Controlled Trial with a nested Cross-Over Trial study design
Scientific title
Using a brief, online, tailored, nutrition messaging intervention to reduce the discretionary choice intake of Australian adults: A Randomised Controlled Trial with a nested Cross-Over Trial study design
Secondary ID [1] 298938 0
None
Universal Trial Number (UTN)
U1111-1238-0824
Trial acronym
MyN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 313926 0
Condition category
Condition code
Diet and Nutrition 312334 312334 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Group 1 (intervention: tailored message group)
Why: The use of message framing as an influential communication strategy has been successful in promoting health related behaviours such as lowering alcohol consumption and reducing smoking. However, the same success has not always been achieved for eating behaviours.
What: Participants will be invited and randomised to intervention or control group. A baseline online questionnaire will measure: intention to reduce discretionary choice intake; diet quality using a validated Short Food Survey; and positive diet-behaviour enablers. The cross-over trial will test differences in Group 1 participants’ reported intention to eat less discretionary choices following exposure to 4 different evidence-based nutrition messages. The cross-over trial will occur at one time-point, at baseline. The messages will be standard within each frame, and provided as text. They will be framed as follows:
• Gain framed nutrition message (53 words)
• Loss framed nutrition message (53 words)
• Majority social norm framed nutrition message (37 words)
• Minority social norm framed nutrition message (40 words)
How: Participants will receive the messages in a random order with washouts lasting for a minimum of 30 seconds each. Following each message, participants will report their intention to change their discretionary food intake, and the nutrition message with the highest intention for change will be the one that is taken forward as part of the individual’s tailored nutrition intervention.
Where, when, how much: Based on the highest intention-to-change score following the message exposures in the cross-over trial, Group 1 participants will receive this message (the one resulting in the highest intention score) as their tailored intervention, via two emails at baseline and Week 2 of the study, each approximately comprising 500 words. These emails will encourage the new behaviour: eat less discretionary choices, using tailored and instructional messages to support the reduction of discretionary choices, guided by the Behaviour Change Wheel ‘COM-B’ framework.
The tailoring approach will be utilised as evidence shows that, in comparison to general messages, more specific and tailored instruction may increase engagement in a behaviour change intervention.
4 weeks after baseline, all participants will receive an email with links to complete follow-up surveys.
Group 1 will be asked to complete a follow-up questionnaire at Week 4 (from baseline) to measure: follow-up intention and diet quality.
Planned fidelity: In the follow-up questionnaire, participants will be asked if and how often intervention emails were read.
Intervention code [1] 315212 0
Lifestyle
Comparator / control treatment
Name: Group 0 (control: standard message group)
What: Participants will be invited and randomised to intervention or control group. A baseline online questionnaire will measure: intention to reduce discretionary choice intake; diet quality using a validated Short Food Survey; and positive diet-behaviour enablers.
Where, when, how much: Group 0 will receive two emails; one at baseline and one at Week 2 of the study providing a standard (non-tailored) message to reduce discretionary choices, without additional behavioural support.
4 weeks after baseline, participants will receive an email with a link to complete follow-up surveys to measure: follow-up intention and diet quality.
Planned fidelity: In the follow-up questionnaire, participants will be asked if and how often intervention emails were read.
Control group
Active

Outcomes
Primary outcome [1] 320962 0
A difference in discretionary choice serve size intake between the intervention group and the control group, assessed via the Short Food Survey (dietary measurement tool).
Timepoint [1] 320962 0
4 weeks post commencement of intervention
Secondary outcome [1] 373525 0
A change in intention scores following message exposures, compared to baseline/'raw' intention score. Intention score assessed as the mean score from 3 internally consistent questionnaire items constructed based on Theory of Planned Behaviour.
Timepoint [1] 373525 0
At baseline, during cross-over trial
Secondary outcome [2] 373917 0
A serve size reduction in discretionary choice intake in the intervention group from baseline to follow-up, assessed via the Short Food Survey (dietary measurement tool).
Timepoint [2] 373917 0
4 weeks post commencement of intervention

Eligibility
Key inclusion criteria
• Adults (aged 18 years or over) currently living in Australia;
• Willing to participate in a brief online nutrition intervention over 4 weeks (and complete 2 surveys during this time);
• Have access to an internet enabled computer, phone or tablet to receive emails;
• Not currently avoiding any major food groups in their diet (wholegrains, fruit, vegetables, dairy and/or alternatives, meat and/or alternatives) or following a special diet for medical reasons.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
There will be a parallel assignment (Intervention and Control groups), and a cross-over assignment (Intervention group only) nested within this
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on an expected 0.25 to 0.35 serve size difference of discretionary choice intake change between the two groups, a-priori power calculations indicated that a sample range of 732 to 1430 participants would give us 80% power to detect the small effect sizes at a significant level of 0.05. An addition of 25% will account for potential drop out of participants not completing the full intervention. Therefore, a sample of between 915 to 1788 participants will be needed.
Data from the cross-over trial will be used to examine if there are any differences in the reported intention to eat less discretionary choices between the 4 nutrition message types. The difference between groups will be assessed by using repeated measures analysis of variance. Post hoc tests (Tukey) will test where the differences occur within the groups. A series of 2-way repeated measures analysis of variance will be performed to identify to which extent moderators effect the reported intention following exposure to a nutrition message.
Data from the follow up surveys of both intervention groups will be used to conduct unpaired (two sample) t-tests to compare the difference in discretionary choice intake change between a brief intervention using tailored nutrition messages (Group 1) and using a standardised message (Group 2). Covariates will be demographic characteristics and baseline consumption of discretionary choices.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2019
Actual
8/09/2019
Date of last participant enrolment
Anticipated
30/06/2021
Actual
29/11/2019
Date of last data collection
Anticipated
Actual
20/12/2019
Sample size
Target
1788
Accrual to date
Final
3453
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303478 0
University
Name [1] 303478 0
Flinders University
Country [1] 303478 0
Australia
Funding source category [2] 303513 0
Commercial sector/Industry
Name [2] 303513 0
The Commonwealth Scientific and Industrial Research Organisation
Country [2] 303513 0
Australia
Funding source category [3] 303514 0
Other Collaborative groups
Name [3] 303514 0
Healthy Development Adelaide
Country [3] 303514 0
Australia
Funding source category [4] 303515 0
Government body
Name [4] 303515 0
Commonwealth Scholarships Program for South Australia - Department of Education
Country [4] 303515 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Commonwealth Scientific and Industrial Research Organisation
Address
SAHMRI, North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 303536 0
University
Name [1] 303536 0
Flinders University
Address [1] 303536 0
Sturt Rd, Bedford Park SA 5042
Country [1] 303536 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304008 0
CSIRO Health and Medical Human Research Ethics Committee (CHM HREC)
Ethics committee address [1] 304008 0
Ethics committee country [1] 304008 0
Australia
Date submitted for ethics approval [1] 304008 0
18/07/2019
Approval date [1] 304008 0
22/07/2019
Ethics approval number [1] 304008 0
2019_051_LR
Ethics committee name [2] 304039 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [2] 304039 0
Ethics committee country [2] 304039 0
Australia
Date submitted for ethics approval [2] 304039 0
22/07/2019
Approval date [2] 304039 0
05/08/2019
Ethics approval number [2] 304039 0
OH-00224

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

Contacts
Principal investigator
Name 95542 0
Dr Gilly Hendrie
Address 95542 0
CSIRO, SAHMRI, North Terrace, Adelaide, SA 5000
Country 95542 0
Australia
Phone 95542 0
+61 08 8305 0662
Fax 95542 0
Email 95542 0
[email protected]
Contact person for public queries
Name 95543 0
Gilly Hendrie
Address 95543 0
CSIRO, SAHMRI, North Terrace, Adelaide, SA 5000
Country 95543 0
Australia
Phone 95543 0
+61 08 8305 0662
Fax 95543 0
Email 95543 0
[email protected]
Contact person for scientific queries
Name 95544 0
Gilly Hendrie
Address 95544 0
CSIRO, SAHMRI, North Terrace, Adelaide, SA 5000
Country 95544 0
Australia
Phone 95544 0
+61 08 8305 0662
Fax 95544 0
Email 95544 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


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.