Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Diet quality among people with multiple sclerosis using personalised digital nutrition education
Query!
Secondary ID [1]
313764
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EWWMS
Query!
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.
Query!
Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis
336369
0
Query!
disability
336374
0
Query!
fatigue
336370
0
Query!
depression
336371
0
Query!
anxiety
336372
0
Query!
Condition category
Condition code
Neurological
333006
333006
0
0
Query!
Multiple sclerosis
Query!
Public Health
333007
333007
0
0
Query!
Health promotion/education
Query!
Inflammatory and Immune System
332901
332901
0
0
Query!
Autoimmune diseases
Query!
Mental Health
333082
333082
0
0
Query!
Depression
Query!
Mental Health
333083
333083
0
0
Query!
Anxiety
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
330347
0
Behaviour
Query!
Intervention code [2]
330346
0
Lifestyle
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
340426
0
Change in diet quality score
Query!
Assessment method [1]
340426
0
Assessed using the Diet Habits Questionnaire (DHQ), a validated tool modified for people with MS. The DHQ measures diet quality across various sub-scores, including intake of fruits, vegetables, omega-3 fatty acids, and overall food preparation habits.
Query!
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
Query!
Secondary outcome [1]
444018
0
Quality of life
Query!
Assessment method [1]
444018
0
Measured using the MSIS-8D, a validated tool for assessing quality-adjusted life years specific to MS populations
Query!
Timepoint [1]
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
Query!
Secondary outcome [2]
444418
0
Symptoms of anxiety
Query!
Assessment method [2]
444418
0
Assessed using the Hospital Anxiety and Depression Scale, a validated 14-item questionnaire (of which 7 items assess anxiety).
Query!
Timepoint [2]
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
Query!
Secondary outcome [3]
444419
0
Feasibility
Query!
Assessment method [3]
444419
0
Measured by participant completion rates and engagement analytics, such as module completion and time spent on the platform. These metrics indicate whether the program is practical and sustainable for participants.
Query!
Timepoint [3]
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
Query!
Secondary outcome [4]
444023
0
Acceptability
Query!
Assessment method [4]
444023
0
evaluated using the Intrinsic Motivation Inventory subscales for interest/enjoyment and value/usefulness. These subscales assess how engaging and valuable participants find the program, providing insight into their satisfaction and willingness to continue.
Query!
Timepoint [4]
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
Query!
Secondary outcome [5]
444017
0
Change in nutrition literacy
Query!
Assessment method [5]
444017
0
Assessed using the Critical Nutrition Literacy Tool, a validated questionnaire that evaluates engagement in healthful dietary behaviors and critical thinking about nutrition claims.
Query!
Timepoint [5]
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
Query!
Secondary outcome [6]
444016
0
Change in food literacy
Query!
Assessment method [6]
444016
0
Assessed using the Food Literacy Behaviour Checklist, which measures knowledge, skills, and behaviors for food planning, preparation, and selection.
Query!
Timepoint [6]
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
Query!
Secondary outcome [7]
444019
0
Fatigue
Query!
Assessment method [7]
444019
0
Measured using the Fatigue Severity Scale (FSS), a validated 9-item questionnaire that evaluates the impact of fatigue on daily activities.
Query!
Timepoint [7]
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
Query!
Secondary outcome [8]
444020
0
Symptoms of depression
Query!
Assessment method [8]
444020
0
Assessed using the Hospital Anxiety and Depression Scale, a validated 14-item questionnaire (of which 7 items assess depression).
Query!
Timepoint [8]
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
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequences will be embedded in Qualtrics ensuring allocation concealment
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
2/06/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/08/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
1/09/2026
Query!
Actual
Query!
Sample size
Target
342
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
318225
0
University
Query!
Name [1]
318225
0
Deakin University Postgraduate Research Scholarship and internal funds
Query!
Address [1]
318225
0
Query!
Country [1]
318225
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Deakin University
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320704
0
None
Query!
Name [1]
320704
0
Query!
Address [1]
320704
0
Query!
Country [1]
320704
0
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
316868
0
Deakin University Human Research Ethics Committee (DUHREC)
Query!
Ethics committee address [1]
316868
0
https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
Query!
Ethics committee country [1]
316868
0
Australia
Query!
Date submitted for ethics approval [1]
316868
0
22/01/2025
Query!
Approval date [1]
316868
0
Query!
Ethics approval number [1]
316868
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
139258
0
Prof Lucinda Black
Query!
Address
139258
0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Query!
Country
139258
0
Australia
Query!
Phone
139258
0
+61 3 924 45491
Query!
Fax
139258
0
Query!
Email
139258
0
[email protected]
Query!
Contact person for public queries
Name
139259
0
Eduard Martinez Solsona
Query!
Address
139259
0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Query!
Country
139259
0
Australia
Query!
Phone
139259
0
+61 3 924 45491
Query!
Fax
139259
0
Query!
Email
139259
0
[email protected]
Query!
Contact person for scientific queries
Name
139260
0
Eduard Martinez Solsona
Query!
Address
139260
0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125, Deakin University
Query!
Country
139260
0
Australia
Query!
Phone
139260
0
+61 3 924 45491
Query!
Fax
139260
0
Query!
Email
139260
0
[email protected]
Query!
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.
Download to PDF