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Trial registered on ANZCTR


Registration number
ACTRN12623000179639
Ethics application status
Approved
Date submitted
25/01/2023
Date registered
21/02/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Veg4Me feasibility study: investigating the effect of digitally-delivered personalised support on vegetable intake in young adults living in rural Australia
Scientific title
Randomised controlled trial to determine the feasibility of delivering a personalised and co-designed intervention and the effect on vegetable intake in young adults (18-35 years) living in rural Australia: the Veg4Me feasibility study
Secondary ID [1] 308360 0
Nil known
Universal Trial Number (UTN)
U1111-1284-9027
Trial acronym
Veg4Me
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient vegetable intake 328172 0
Condition category
Condition code
Public Health 325224 325224 0 0
Health promotion/education
Public Health 325225 325225 0 0
Other public health
Diet and Nutrition 325227 325227 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is feasibility trial where participants will be provided 12 weeks' access to the Veg4Me web application. There are two groups: Intervention group (personalised content on the Veg4Me web application) and control group (non-personalised content on the Veg4Me web application).

Veg4Me is a web application that has been co-designed and developed by young adults (18–35 years), local governments, the National Heart Foundation of Australia, web developers and the research team, to personalise intervention content to participants’ local food environment and individual preferences. It is underpinned by established behaviour change techniques, including the self-determination theory and the behaviour change wheel. It has been informed by the nonadoption, abandonment, scale-up, spread, and sustainability framework, as well as intervention mapping and feature and function prioritisation in co-design and prototyping workshops.

The features of the personalised web application include:
- Personalised local food environment map: At baseline, participants randomised to the intervention group will select the local government area they live in, which will tailor a local food environment map to their local area. This map is a modified Google map with colour-coded icons reflecting different local food resources and initiatives. These resources include foodbanks, community gardens, cooking clubs and food producers identified by young adults and local governments from each area. Each icon contains a brief description of the resource, as well as a link to Google maps for participants to access more information.

- Personalised recipes and healthy eating resources: Participants randomised to the intervention will receive a new set of personalised recipes for each of the 12 weeks of the intervention. These will be displayed based on personalisation questions in the baseline survey where participants will indicate whether they eat meat (yes/no), and whether they prefer recipes with shorter or longer preparation times (<30 mins/>30 mins). Participants will also have access to a recipe library of approximately 240 recipes. All recipes have been designed by the National Heart Foundation of Australia (https://www.heartfoundation.org.au/) to be heart healthy and affordable. Recipes will be supported by healthy eating resources to help participants develop knowledge, confidence, and skills to increase vegetable intake. These resources will come from a range of government and non-government organisations in Australia (e.g. https://nutritionaustralia.org/) as well as resources on vegetables designed specifically for this study. The format of these resources will include images and written material.

- Goal setting and tracking: Participants will be prompted to set a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) goal for each week of the intervention. The web application allows researchers to set up a recurring weekly email, which will be sent to the participant at the end of each week to allow the user to plan for the week ahead. In this weekly contact, participants will be encouraged to engage with the web application throughout the week to help them meet their goal (the amount of time will be left to the participants' own discretion). A mid-week reminder will be sent via email to encourage participants to action their goal. Goals can be selected from a drop-down option or a free text box where they can set their own goal. These goals will be monitored by research staff to ensure they are diet-related, and participants contacted with suggestions if they are not deemed diet-related. Example goals will include “Prepare at least two recipes this week”; “Visit at least one of the places on your food map this week”; “Eat an additional serve of vegetables every day this week”. Participants will be prompted to set, self-monitor and reflect on their goals weekly.

- Personalised weekly newsletter: To support participant retention and prompt participants to access Veg4Me and review their weekly goals, a personalised weekly e-newsletter developed and disseminated by the research team will be delivered via email to participants. This newsletter will be ~1 page in length and will take participants 5-10 minutes to read.

Engagement with the Veg4Me web application will be measured throughout the intervention period via the web application.
Intervention code [1] 324828 0
Lifestyle
Intervention code [2] 324829 0
Behaviour
Comparator / control treatment
Participants in the control group will receive 12 weeks’ access to a non-personalised recipe library and food environment resources. The recipes within the recipe library will be the same ~240 as those in the personalised recipe library and have been designed by the National Heart Foundation of Australia (https://www.heartfoundation.org.au/) to be heart healthy and affordable. The food environment resources provided to the control group will be presented as a list of resources, rather than the interactive map presented in the intervention group. This list will include all resources identified for all local government areas included in the trial, rather than centered on the participant's local government area presented in the intervention group.

Engagement with the Veg4Me web application will be measured throughout the intervention period via the platform.
Control group
Active

Outcomes
Primary outcome [1] 333694 0
Feasibility of the Veg4Me web application defined as recruitment rate: recruitment rate (%) is the total number of individuals randomised/ total number who completed user account registration
Timepoint [1] 333694 0
Assessed continuously throughout the recruitment period
Primary outcome [2] 333695 0
Feasibility of the Veg4Me web application defined as participation: participation rate (%) is the total number of eligible participants randomised who complete baseline survey/ total number eligible at baseline
Timepoint [2] 333695 0
Cumulative data will be assessed at the conclusion of the study
Primary outcome [3] 333696 0
Feasibility of the Veg4Me web application defined as retention: retention rate (%) is total number of participants who completed follow-up/ total number who were randomised into the study.
Timepoint [3] 333696 0
Week 12 (end of intervention)
Secondary outcome [1] 417961 0
Web application engagement: log-ins passively collected via the in-built web application platform tracking (and Google Analytics where possible)
Timepoint [1] 417961 0
Continuously throughout the intervention period (12 weeks)
Secondary outcome [2] 417962 0
Web application engagement: visits to pages passively collected via the in-built web application platform tracking (and Google Analytics where possible)
Timepoint [2] 417962 0
Continuously throughout the intervention period (12 weeks)
Secondary outcome [3] 417963 0
Update Web application engagement: time of day accessed passively collected via the in-built web application platform tracking (and Google Analytics where possible)
Timepoint [3] 417963 0
Continuously throughout the intervention period (12 weeks)
Secondary outcome [4] 417964 0
Web application engagement: number of sessions passively collected via the in-built web application platform tracking (and Google Analytics where possible)
Timepoint [4] 417964 0
Continuously throughout the intervention period (12 weeks)
Secondary outcome [5] 417965 0
Web application engagement: duration of sessions passively collected via the in-built web application platform tracking (and Google Analytics where possible)
Timepoint [5] 417965 0
Continuously throughout the intervention period (12 weeks)
Secondary outcome [6] 417967 0
Web application usability: assessed via the 16-item Post-Study System Usability Questionnaire (PSSUQ)
Timepoint [6] 417967 0
Week 12 (end of intervention)
Secondary outcome [7] 417970 0
Experience with web application: assessed via Qualtrics as experience with the recipe resources (this question has been designed specifically for this study)
Timepoint [7] 417970 0
Week 12 (end of intervention)
Secondary outcome [8] 417972 0
Experience with web application: assessed via Qualtrics as experience with the food environment resources (this question has been designed specifically for this study)
Timepoint [8] 417972 0
Week 12 (end of intervention)
Secondary outcome [9] 417973 0
Experience with web application: assessed via Qualtrics as experience with the healthy eating resources (intervention group only; this question has been designed specifically for this study)
Timepoint [9] 417973 0
Week 12 (end of intervention)
Secondary outcome [10] 417974 0
Experience with web application: assessed via Qualtrics as experience with the goal setting function (intervention group only; this question has been designed specifically for this study)
Timepoint [10] 417974 0
Week 12 (end of intervention)
Secondary outcome [11] 417975 0
Experience with web application: assessed via Qualtrics as experience with the newsletters (intervention group only; this question has been designed specifically for this study)
Timepoint [11] 417975 0
Week 12 (end of intervention)
Secondary outcome [12] 417976 0
Experience with web application: assessed via Qualtrics as overall experience with the Veg4Me web application (this question has been designed specifically for this study)
Timepoint [12] 417976 0
Week 12 (end of intervention)
Secondary outcome [13] 417977 0
Eating habits: vegetable intake (serves/day): assessed via a validated brief diet question (Riley et al 2001)
Timepoint [13] 417977 0
Baseline, Week 12 (end of intervention)
Secondary outcome [14] 417978 0
Eating habits: assessed via a question on cooking confidence (12-item composite score; adapted from HEA Survey Health and Lifestyle Survey)
Timepoint [14] 417978 0
Baseline, Week 12 (end of intervention)
Secondary outcome [15] 417979 0
Eating habits: assessed via a question on self-efficacy to eat healthy (3-item composite score; adapted from Sallis 1988)
Timepoint [15] 417979 0
Baseline, Week 12 (end of intervention)
Secondary outcome [16] 417980 0
Eating habits: assessed via a validated question on self-efficacy to eat vegetables (7-item composite score; Mainvil et al 2009)
Timepoint [16] 417980 0
Baseline, Week 12 (end of intervention)
Secondary outcome [17] 417981 0
Eating habits: assessed via a question on readiness for change in eating habits (adapted based on the Transtheoretical Model)
Timepoint [17] 417981 0
Baseline, Week 12 (end of intervention)
Secondary outcome [18] 417982 0
Eating habits: assessed via a question on changes in vegetable intake (this question has been designed specifically for this study)
Timepoint [18] 417982 0
Week 12 (end of intervention)
Secondary outcome [19] 417983 0
Eating habits: assessed via a question on changes in food shopping (this question has been designed specifically for this study)
Timepoint [19] 417983 0
Week 12 (end of intervention)
Secondary outcome [20] 417984 0
Eating habits: assessed via a question on changes in food preparation (this question has been designed specifically for this study)
Timepoint [20] 417984 0
Week 12 (end of intervention)
Secondary outcome [21] 417985 0
Eating habits: assessed via a question on facilitators (capability and motivation) to increasing vegetable intake 1 (this question has been adapted from the Behavior Change Wheel COM-B model)
Timepoint [21] 417985 0
Week 12 (end of intervention)
Secondary outcome [22] 418533 0
Eating habits: assessed via a question on facilitators (capability, opportunity and motivation) to increasing vegetable intake 2 (this question has been adapted from the Behavior Change Wheel COM-B model)
Timepoint [22] 418533 0
Week 12 (end of intervention)
Secondary outcome [23] 418534 0
Eating habits: assessed via a question on facilitators (capability and motivation) to increasing vegetable intake 3 (this question has been adapted from the Behavior Change Wheel COM-B model)
Timepoint [23] 418534 0
Week 12 (end of intervention)
Secondary outcome [24] 418535 0
Digital device equity: assessed via a question on digital literacy aligned with a framework for digital health equity (Richardson et al 2022)
Timepoint [24] 418535 0
Baseline, Week 12 (end of intervention)
Secondary outcome [25] 425913 0
Digital device equity: assessed via a question on digital self-efficacy aligned with a framework for digital health equity (Richardson et al 2022)
Timepoint [25] 425913 0
Baseline, Week 12 (end of intervention)
Secondary outcome [26] 425914 0
Digital device equity: assessed via a question on technology access aligned with a framework for digital health equity (Richardson et al 2022)
Timepoint [26] 425914 0
Baseline, Week 12 (end of intervention)
Secondary outcome [27] 425915 0
Digital device equity: assessed via a question on attitudes towards technology use aligned with a framework for digital health equity (Richardson et al 2022)
Timepoint [27] 425915 0
Baseline, Week 12 (end of intervention)
Secondary outcome [28] 425916 0
Semi-structured interviews: assessed via online interview to understand what worked, why and for whom with Veg4Me
Timepoint [28] 425916 0
Week 12 (end of intervention)

Eligibility
Key inclusion criteria
1. adults aged 18–35 years (inclusive) living in the Loddon Campaspe municipalities (City of Greater Bendigo, Campaspe, Central Goldfields, Greater Bendigo, Loddon, Macedon Ranges and Mount Alexander) or Colac Otway Shire
2. currently eat <5 serves of vegetables/day
3. have access to a mobile device or computer/laptop
4. have internet connection
5. willing/able to access a free web application
6. able to provide written informed consent to participate in the study
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. cannot understand and read English
2. are pregnant or breastfeeding
3. are currently participating in another research trial involving a behaviour change intervention

Participants with medical conditions, such as type 1 diabetes, who require specific clinical nutrition advice, will be advised to visit their general practitioner to obtain medical clearance before participating in the study and asked to indicate that they will do this before providing consent.

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)
Allocation concealment will be as per central computerised randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in permuted blocks using random blocks of varying size and stratified by location (Loddon Campaspe and Colac Otway Shire) and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In line with good practice guidelines for feasibility trials, we aim to analyse 120 participants (60 per group), and expect 20% dropout. Therefore, 150 participants will be recruited.

Data analyses will be conducted on an intention to treat basis. Feasibility outcomes will be compared to benchmarks of success. Descriptive statistics will be reported for all outcomes for the personalised and non-personalised groups at baseline and 12 weeks.

Generalised linear models (with appropriate family and link functions) will be used to evaluate group differences on outcomes at 12 weeks adjusted for baseline levels of the outcome and stratifying factors.

Both multiple imputation (primary analysis) and complete case analyses will be conducted. Missing outcome data will be handled using multiple imputation by chained equations with stratification factors and age included as auxiliary variables, with imputation performed separately by study group.

Thematic analysis will be performed on qualitative data

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2023
Actual
8/08/2023
Date of last participant enrolment
Anticipated
31/01/2024
Actual
1/02/2024
Date of last data collection
Anticipated
30/04/2024
Actual
14/05/2024
Sample size
Target
150
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312601 0
Charities/Societies/Foundations
Name [1] 312601 0
National Heart Foundation of Australia
Country [1] 312601 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
Melbourne Burwood Campus
221 Burwood Highway
Burwood 3125
VICTORIA
Country
Australia
Secondary sponsor category [1] 314603 0
None
Name [1] 314603 0
Address [1] 314603 0
Country [1] 314603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311927 0
Deakin University Human Ethics Advisory Group - Faculty of Health
Ethics committee address [1] 311927 0
The Human Research Ethics Office
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Ethics committee country [1] 311927 0
Australia
Date submitted for ethics approval [1] 311927 0
25/01/2023
Approval date [1] 311927 0
06/03/2023
Ethics approval number [1] 311927 0
HEAG-H 06_2023

Summary
Brief summary
Australians living in rural and regional communities are more likely to die early and experience higher rates of preventable disease than those living in the cities, resulting in higher rates of risk factors for chronic diseases, such as high blood pressure and obesity, and higher burden on health care systems. Rural communities also have reduced access to nutrition professionals than metropolitan communities, mostly due to health care workforce challenges and geographical barriers. Diets low in vegetables are a main contributor to the health burden experienced by rural Australians, which is further compounded by unhealthful rural food environments, and socioeconomic inequities. Yet, only 8% of Australians meet recommended intakes, and this is as few as 3% in young adults living in rural areas.

Digital health solutions, such as mobile and web-applications, offer an accessible, scalable and inexpensive delivery model for rapid translation of interventions into rural communities that can be personalised to meet the needs of the user. As most adults own a digital device, such as a smartphone, digital health interventions provide an suitable solution for interventions to increase vegetable consumption, However, digital health solutions will have limited success without addressing the needs of rural communities.

An increasing body of literature is engaging with the community for the design of digital interventions, rather than for the community, to ensure it meets the need of the target population and there is evidence that co-designed interventions can result in improved engagement and experience of the user, as well as improved dietary intake.

This feasibility randomised controlled trial will investigate the feasibility and acceptability of a co-designed and personalised web application (Veg4Me) compared with a non-personalised web application, to address unique barriers to vegetable intake experienced by young adults living in rural areas of Victoria.

If feasible, this intervention will be examined for effectiveness for increasing vegetable intake and to understand context for implementation in rural communities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122866 0
Dr Katherine Livingstone
Address 122866 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
Melbourne Burwood Campus
221 Burwood Highway
Burwood 3125
VICTORIA
Country 122866 0
Australia
Phone 122866 0
+61 3 9244 5416
Fax 122866 0
Email 122866 0
[email protected]
Contact person for public queries
Name 122867 0
Katherine Livingstone
Address 122867 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
Melbourne Burwood Campus
221 Burwood Highway
Burwood 3125
VICTORIA
Country 122867 0
Australia
Phone 122867 0
+61 3 9244 5416
Fax 122867 0
Email 122867 0
[email protected]
Contact person for scientific queries
Name 122868 0
Katherine Livingstone
Address 122868 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
Melbourne Burwood Campus
221 Burwood Highway
Burwood 3125
VICTORIA
Country 122868 0
Australia
Phone 122868 0
+61 3 9244 5416
Fax 122868 0
Email 122868 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
No IPD will be shared as this will not meet the requirements for ethics approval.


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.