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Trial registered on ANZCTR


Registration number
ACTRN12625000168459p
Ethics application status
Submitted, not yet approved
Date submitted
21/01/2025
Date registered
13/02/2025
Date last updated
13/02/2025
Date data sharing statement initially provided
13/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Diet quality among people with multiple sclerosis using personalised digital nutrition education
Scientific title
Diet quality among people with multiple sclerosis using personalised digital nutrition education
Secondary ID [1] 313764 0
None
Universal Trial Number (UTN)
Trial acronym
EWWMS
Linked study record
ACTRN12622000276752 was the pilot study of this trial. The current trial is the second version, which will be larger in sample size and contain updates and improvements in the program content.

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 336369 0
fatigue 336370 0
depression 336371 0
anxiety 336372 0
disability 336374 0
Condition category
Condition code
Inflammatory and Immune System 332901 332901 0 0
Autoimmune diseases
Neurological 333006 333006 0 0
Multiple sclerosis
Public Health 333007 333007 0 0
Health promotion/education
Mental Health 333082 333082 0 0
Depression
Mental Health 333083 333083 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Eating Well with MS (EWWMS) program is a six-week online nutrition education initiative designed to help individuals with Multiple Sclerosis (MS) improve their diet quality. The program provides evidence-based nutrition education aligned with Australian Dietary Guidelines and incorporates behavior change techniques such as goal setting, action planning, and problem-solving strategies. Each week, participants access a new online module containing written materials, infographics, videos, and moderated discussion boards for community engagement. The program also includes symptom-specific dietary guidance tailored to MS-related issues such as fatigue, constipation, and weight management. The materials were co-designed with individuals living with MS and developed using an evidence-based approach. While the content is rooted in the Australian Dietary Guidelines, it has been uniquely tailored for MS, incorporating insights from consumer panels and stakeholders to meet the specific needs of participants. A registered nutritionist with MS expertise moderates the forums to provide support. Additionally, a 3-month booster online module reinforces long-term dietary changes, helping participants maintain progress. Access to all the modules will remain available until two weeks after the 3-month refresher module.

The program consists of several key modules that guide participants through essential topics in nutrition and MS management:

- Introduction to healthy eating with MS, explaining the benefits of a balanced diet for symptom management and fatigue reduction.
- Food preparation and cooking skills, focusing on reading food labels, modifying recipes, and meal planning to optimize energy levels.
- Making dietary changes to achieve goals, addressing eating habits, goal-setting, and strategies for long-term healthy eating.
- Personalizing food choices, aligning diet with the Australian Dietary Guidelines while accommodating individual preferences.
- Special diets for MS, critically evaluating marketed diets and their evidence-based effectiveness.
- Understanding research, covering diet research challenges and the latest findings on MS nutrition.
- A refresher module (after 3 months), reinforcing the most relevant dietary information and supporting long-term behavior change.

We expect a duration of around 1 hour/week to complete each module. However, the program is self-paced, allowing participants to complete modules at their convenience before the program ends. Offline activities include access to additional healthy eating resources from the Australian Dietary Guidelines, specifically the Australian Guide to Healthy Eating brochure and associated graphics. The intervention ensures accessibility and personalization, making it a valuable tool for dietary behavior change among individuals with MS.
Intervention code [1] 330346 0
Lifestyle
Intervention code [2] 330347 0
Behaviour
Comparator / control treatment
the control arm involves participants receiving links to publicly available online resources that provide general dietary guidance, specifically the Australian Guide to Healthy Eating brochure and associated graphics. These materials are delivered via email or online links for self-paced access. The resources are generic and not tailored to the specific needs or conditions of individuals with MS. After the 12-month study period, participants in the control group will be offered access to the EWWMS program.
Control group
Active

Outcomes
Primary outcome [1] 340426 0
Change in diet quality score
Timepoint [1] 340426 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes (primary timepoint)
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [1] 444016 0
Change in food literacy
Timepoint [1] 444016 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [2] 444017 0
Change in nutrition literacy
Timepoint [2] 444017 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [3] 444018 0
Quality of life
Timepoint [3] 444018 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [4] 444019 0
Fatigue
Timepoint [4] 444019 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [5] 444020 0
Symptoms of depression
Timepoint [5] 444020 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [6] 444023 0
Acceptability
Timepoint [6] 444023 0
1. 6 weeks: Program finishes
2. Follow-up 3 months: after the 3-months refresher module
3. 12 months follow-up after the start of the program
Secondary outcome [7] 444418 0
Symptoms of anxiety
Timepoint [7] 444418 0
1. Baseline: Beginning of the digital program and reception of Australian Dietary Guidelines resources
2. 6 weeks: Program finishes
3. Follow-up 3 months: after the 3-months refresher module
4. 6 months, 9 months, and 12 months follow-up after the start of the program
Secondary outcome [8] 444419 0
Feasibility
Timepoint [8] 444419 0
1. 6 weeks: Program finishes
2. Follow-up 3 months: after the 3-months refresher module
3. 12 months follow-up after the start of the program

Eligibility
Key inclusion criteria
The inclusion criteria will be: >=18 years, diagnosed with any type of MS (diagnosis confirmed by membership of an MS service provider as a person with MS, or letter from GP/neurologist), can read/write/speak English, does not require medical nutrition therapy (e.g., tailored nutrition treatment for a medical condition such as dysphagia, provided by a dietitian), did not participate in the pilot study of Eating Well with MS, have not completed any online nutrition programs or are currently seeing a dietitian (to avoid confounding effects of previous program participation or making current dietary changes informed by a dietitian), and has internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals younger than 18 will be excluded as the study focuses on adults with MS.

Potential participants without a confirmed MS diagnosis.

Individuals residing outside of Australia will be excluded due to the program's focus on the Australian healthcare context and its alignment with national dietary guidelines.

Participants unable to read or understand English will be excluded as the program and surveys are delivered exclusively in English, and translation services are not available.

Individuals without reliable internet access or a compatible device (e.g., computer, tablet, smartphone) will be excluded, as the program is delivered entirely online.

Previously completed any online nutrition education program

Currently seeing a dietitian in relation to a health condition

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)
Eligible participants will be randomised (1:1) stratified by sex. After randomisation, participants will be unblinded to group assignment. Research personnel assessing outcomes and the data analyst will be blind to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequences will be embedded in Qualtrics ensuring allocation concealment
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
Efficacy
Statistical methods / analysis
The statistical analysis will follow an intention-to-treat approach, ensuring that all randomized participants are included in the analysis regardless of adherence. Linear mixed models will be used to assess changes in dietary behavior over time, with fixed effects for time, group assignment, and their interaction. Covariates such as baseline dietary intake, demographics, and MS symptom severity will be included to control for potential confounding factors. Secondary analyses will examine engagement metrics, feasibility, and acceptability outcomes using descriptive statistics and regression models.

The sample size was determined based on detecting a clinically meaningful change in diet quality with 80% power at a 5% significance level. Assuming an effect size of 0.36 and an expected 30% attrition rate, a total of 342 participants (171 per group) will be recruited to ensure sufficient power to detect intervention effects across multiple timepoints. Missing data will be handled using multiple imputation techniques.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
342
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318225 0
University
Name [1] 318225 0
Deakin University Postgraduate Research Scholarship and internal funds
Country [1] 318225 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320704 0
None
Name [1] 320704 0
Address [1] 320704 0
Country [1] 320704 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316868 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316868 0
https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
Ethics committee country [1] 316868 0
Australia
Date submitted for ethics approval [1] 316868 0
22/01/2025
Approval date [1] 316868 0
Ethics approval number [1] 316868 0

Summary
Brief summary
The Eating Well with MS study aims to evaluate the effectiveness of an online nutrition education program designed to improve diet quality and food literacy in people living with multiple sclerosis (MS). We hypothesize that participants who complete the program will demonstrate significant improvements in their diet quality, food literacy, and overall quality of life, symptoms, and disease progression, compared to those receiving standard care. The study seeks to provide accessible and practical tools to support healthier eating habits in individuals with MS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139258 0
Prof Lucinda Black
Address 139258 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Country 139258 0
Australia
Phone 139258 0
+61 3 924 45491
Fax 139258 0
Email 139258 0
[email protected]
Contact person for public queries
Name 139259 0
Eduard Martinez Solsona
Address 139259 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Country 139259 0
Australia
Phone 139259 0
+61 3 924 45491
Fax 139259 0
Email 139259 0
[email protected]
Contact person for scientific queries
Name 139260 0
Eduard Martinez Solsona
Address 139260 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Country 139260 0
Australia
Phone 139260 0
+61 3 924 45491
Fax 139260 0
Email 139260 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
IDP will not be shared to protect participant privacy and confidentiality. While the data will remain re-identifiable to facilitate communication and participation, the unique nature of the dataset and the specific characteristics of the participant group may pose a risk of re-identification. To mitigate this, strict security measures will be in place, and access will be limited exclusively to the research team.


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.