Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000335493p
Ethics application status
Submitted, not yet approved
Date submitted
14/02/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Online healthy and sustainable nutrition program for young adults
Scientific title
Feasibility of an online nutrition intervention on adherence to healthy and sustainable diets in young Australia adults: a pilot pre-post intervention study
Secondary ID [1] 313974 0
Nil known
Universal Trial Number (UTN)
U1111-1319-0745
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unhealthy diets 336696 0
Condition category
Condition code
Public Health 333196 333196 0 0
Health promotion/education
Diet and Nutrition 333442 333442 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pilot intervention will be conducted online via the Deakin Wellbeing Application (mobile application), over a four-week period. The pilot intervention will include educational information only, and no dietary plans will be provided. The information will be scheduled as content posts/ notifications and more detailed resources e.g. health benefits of nuts, can be accessed in an 'Explore' tab. Content posts/ notifications will be scheduled three to four times a week and each post takes less than five minutes to engage with, though, they will be encouraged to use other aspects of the application, which may take more time. It is expected that total usage time will not surpass more than one hour per week. Types of content includes short videos, podcasts, infographics and blogs about the importance of healthy and sustainable eating, and practical strategies e.g. snack swaps. Content will either be self-created by a team of nutritionists and dietitians with at least two years of experience, or sourced from third party sources e.g. dietitians/ nutritionists on Instagram, with permission obtained. There is also a healthy eating habit section where participants can log in and track habits that they've completed e.g. substituted meat with legumes. Participants will also have the opportunity to comment or ask questions for each habit on the healthy eating habit section. A trained nutritionist/ dietitian will moderate these discussions. Another feature is the healthy eating challenge where participants attempt to make meals from the 'Planetary Health Diet recipe challenge' for an incentive. All data collection will also occur online i.e. Qualtrics surveys and within the Deakin Wellbeing Application. As the study is a feasibility trial, usage and interaction of the app will be left to the participants' discretion.
Intervention code [1] 330561 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340757 0
Retention rate
Timepoint [1] 340757 0
Follow-up (one week proceeding four-week intervention)
Primary outcome [2] 340758 0
Recruitment rate
Timepoint [2] 340758 0
Follow-up (one week proceeding four-week intervention)
Secondary outcome [1] 445002 0
Engagement i.e. number of logins, visits to tabs and duration of sessions
Timepoint [1] 445002 0
Follow-up (one week proceeding four-week intervention)
Secondary outcome [2] 445003 0
Sustainable food knowledge
Timepoint [2] 445003 0
Baseline (one week before the intervention starts) and follow-up (one week proceeding four-week intervention)
Secondary outcome [3] 445004 0
World Index for Sustainability and Health (WISH) diet index score
Timepoint [3] 445004 0
Baseline (one week before the intervention starts) and follow-up (one week proceeding four-week intervention)
Secondary outcome [4] 445788 0
User experience (app)
Timepoint [4] 445788 0
Follow-up (one week proceeding four-week intervention)
Secondary outcome [5] 445790 0
User experience (intervention functions)
Timepoint [5] 445790 0
Follow-up (one week proceeding four-week intervention)
Secondary outcome [6] 445791 0
Food skills
Timepoint [6] 445791 0
Baseline (one week before the intervention starts) and follow-up (one week proceeding four-week intervention)
Secondary outcome [7] 445794 0
Attitudes towards healthy and sustainable diets
Timepoint [7] 445794 0
Baseline (one week before the intervention starts) and follow-up (one week proceeding four-week intervention)
Secondary outcome [8] 445795 0
Action intent and action strategies towards healthy and sustainable diets
Timepoint [8] 445795 0
Baseline (one week before the intervention starts) and follow-up (one week proceeding four-week intervention)

Eligibility
Key inclusion criteria
• Aged 18-25 years
• Currently living in Australia
• Consumes below the Planetary Health Diet recommendations for legumes (260g/week) or nuts (175g/week)
• Has an Android (at least Android 7.0 or later) or Apple (at least iOS 14.0 or later) smartphone
• Can understand written and verbal English
Is currently a Deakin staff or student (Deakin Wellbeing application is only available for staff and students)
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pregnant/ breastfeeding women
• Legume e.g. soy, or nut allergies

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative data analysis will be conducted using Stata version 18. Descriptive statistics will be reported for process evaluation measures i.e. user experience (usability and feature ratings), program engagement, response and retention rates. Response rate will be calculated by measuring the total number of eligible participants who complete the baseline survey divided by the total number eligible at baseline. Retention rate will be calculated by measuring the total number of participants who completed the 4-week follow-up divided by the total number who were recruited into the study. Pre- and post-intervention changes in sustainable food literacy, and consumption of food groups (serves per day) e.g. fruit, vegetable, grains, meat and alternatives, dairy and alternatives, will be assessed using the survey data. Paired samples t-tests will be used to compare the means of these outcomes pre- and post-intervention. Qualitative data analysis on open-ended questions will be conducted on NVivo 15.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
14/07/2025
Actual
Date of last data collection
Anticipated
15/08/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318471 0
University
Name [1] 318471 0
Deakin University Higher Degree by Research funding
Country [1] 318471 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320872 0
None
Name [1] 320872 0
Address [1] 320872 0
Country [1] 320872 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317086 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 317086 0
Ethics committee country [1] 317086 0
Australia
Date submitted for ethics approval [1] 317086 0
19/02/2025
Approval date [1] 317086 0
Ethics approval number [1] 317086 0

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

Contacts
Principal investigator
Name 139954 0
Dr Claire Margerison
Address 139954 0
Deakin University, 221 Burwood Highway Burwood Victoria 3125 Australia
Country 139954 0
Australia
Phone 139954 0
+61392445487
Fax 139954 0
Email 139954 0
[email protected]
Contact person for public queries
Name 139955 0
Claire Margerison
Address 139955 0
Deakin University, 221 Burwood Highway Burwood Victoria 3125 Australia
Country 139955 0
Australia
Phone 139955 0
+61392445487
Fax 139955 0
Email 139955 0
[email protected]
Contact person for scientific queries
Name 139956 0
Claire Margerison
Address 139956 0
Deakin University, 221 Burwood Highway Burwood Victoria 3125 Australia
Country 139956 0
Australia
Phone 139956 0
+61392445487
Fax 139956 0
Email 139956 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24542Informed consent form    Study3_PLS_final.docx



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.