ANZCTR - Registration

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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]

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

disability

fatigue

depression

anxiety

Condition category

Condition code

Neurological

Multiple sclerosis

Public Health

Health promotion/education

Inflammatory and Immune System

Autoimmune diseases

Mental Health

Depression

Mental Health

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]

Behaviour

Intervention code [2]

Lifestyle

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]

Change in diet quality score

Timepoint [1]

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]

Quality of life

Timepoint [1]

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]

Symptoms of anxiety

Timepoint [2]

Secondary outcome [3]

Feasibility

Timepoint [3]

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 [4]

Acceptability

Timepoint [4]

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 [5]

Change in nutrition literacy

Timepoint [5]

Secondary outcome [6]

Change in food literacy

Timepoint [6]

Secondary outcome [7]

Fatigue

Timepoint [7]

Secondary outcome [8]

Symptoms of depression

Timepoint [8]

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?

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]

University

Name [1]

Deakin University Postgraduate Research Scholarship and internal funds

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2025

Approval date [1]

Ethics approval number [1]

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

Prof Lucinda Black

Address

Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University

Country

Australia

Phone

+61 3 924 45491

Fax

[email protected]

Contact person for public queries

Name

Eduard Martinez Solsona

Address

Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University

Country

Australia

Phone

+61 3 924 45491

Fax

[email protected]

Contact person for scientific queries

Name

Eduard Martinez Solsona

Address

Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University

Country

Australia

Phone

+61 3 924 45491

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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.

Trial Review

Documents added manually

Documents added automatically