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Trial registered on ANZCTR


Registration number
ACTRN12622000276752
Ethics application status
Approved
Date submitted
28/01/2022
Date registered
14/02/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing and implementing an online nutrition education program for people with multiple sclerosis
Scientific title
Feasibility and efficacy of an online nutrition education program for people with multiple sclerosis
Secondary ID [1] 306313 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 325068 0
Condition category
Condition code
Diet and Nutrition 322502 322502 0 0
Other diet and nutrition disorders
Neurological 322503 322503 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves implementing a pilot study of an online nutrition education program for people with multiple sclerosis (MS). The nutrition education program will be hosted on a secure online learning platform (Moodle). The program will be asynchronous, where one module will be released each week at a set time over 6 weeks, and participants will aim to complete each module within the week. The anticipated time to complete each module will be approximately one hour.
The topics to be included in the online nutrition education program: framing the Australian Dietary Guidelines for people with MS; MS symptoms and nutrition; gut health; foods to eat and avoid; recipes; meal-planning; nutrients and supplements (vitamin D, omega-3 and omega-6 fats, antioxidants, and vitamin B6); understanding evidence-based research; current and emerging dietary research; and “special MS” diets. The online delivery includes written information, interactive graphics, and video clips featuring MS healthcare professionals and people with MS sharing their expertise and experiences. Participants will also receive a hard-copy workbook with activities related to each of the program modules, including goal-setting. The workbook has been specifically designed for this study. Participants will also be encouraged to post in the online discussion board threads. The duration of time that participants will be expected to spend on the activities and discussion board threads will be up to 15 minutes per week, at the participant's own discretion.

Website analytics will be used to monitor adherence to the intervention, including duration spent on each weekly module and engagement in discussion board threads.
Intervention code [1] 322737 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330292 0
Feasibility (demand). Demand will be assessed by measuring participant recruitment ("perceived demand"; were a sufficient number of participants recruited; yes/no), and length of time required for recruitment (were 76 participants recruited within 6 weeks; yes/no). Data will be collected via an audit of study records.
Timepoint [1] 330292 0
At the conclusion of the program.
Primary outcome [2] 330293 0
Feasibility (practicality). Practicality will be assessed by measuring time spent on each module (actual use) and participant completion (ability of participants to carry out the nutrition education program activities). The proportion of participants (%) that complete each module and participant retention for the entire program will be reported. Data for this outcome will be assessed via website analytics.
Timepoint [2] 330293 0
Time spent on each module, participant completion for each module, and participant retention will be measured at conclusion of the program.
Primary outcome [3] 330294 0
Feasibility (acceptability). Acceptability will be assessed using the interest/enjoyment and the value/usefulness subscales of the Intrinsic Motivation Inventory.
Timepoint [3] 330294 0
At the conclusion of the program.
Secondary outcome [1] 405610 0
Diet quality assessed using the Diet Habits Questionnaire
Timepoint [1] 405610 0
Pre- and Post-program (6 weeks)
Secondary outcome [2] 411043 0
Nutrition literacy assessed using the Critical Nutrition Literacy Tool
Timepoint [2] 411043 0
Pre- and Post-program (6 weeks)
Secondary outcome [3] 411044 0
Food literacy behaviour assessed using the Food Literacy Behaviour Checklist
Timepoint [3] 411044 0
Pre- and Post-program (6 weeks)
Secondary outcome [4] 411045 0
Fatigue assessed using the Fatigue Severity Score
Timepoint [4] 411045 0
Pre- and Post-program (6 weeks)
Secondary outcome [5] 411046 0
Depression assessed using the Hospital Anxiety and Depression Scale
Timepoint [5] 411046 0
Pre- and Post-program (6 weeks)
Secondary outcome [6] 411047 0
Anxiety assessed using the Hospital Anxiety and Depression Scale
Timepoint [6] 411047 0
Pre- and Post-program (6 weeks)
Secondary outcome [7] 411048 0
Disability assessed using the Patient-Determined Disease Steps
Timepoint [7] 411048 0
Pre- and Post-program (6 weeks)
Secondary outcome [8] 411049 0
Stage of change assessed using the Healthy Dietary Stages of Change tool
Timepoint [8] 411049 0
Pre- and Post-program (6 weeks)

Eligibility
Key inclusion criteria
People who are aged equal to or greater than 18 years; have been diagnosed with MS; able to speak and understand English; have not previously used an online dietary education program; and have internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requires medical nutrition therapy (tailored nutrition advice for a medical condition such as dysphagia, provided by a dietitian); have previously taken part in the focus groups or cognitive interviews that were conducted during the development stage of the nutrition program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis
Reporting for categorical data will use frequency and percentages; means and standard deviation will be reported for normally distributed continuous data, and median and interquartile range for skewed distributions. An intention-to-treat analysis will be used, incorporating all participants that began the program, regardless of adherence to the program or premature drop-out.

Aim 1: To test the feasibility of an online nutrition education program for people with MS

The feasibility outcomes to be assessed have been guided by the United States National Cancer Institute framework for feasibility studies. These outcomes include demand, practicality, and acceptability.

Hypothesis 1: An online nutrition education program for people with MS can meet demand.
Demand will be assessed by measuring participant recruitment ("perceived demand"; were a sufficient number of participants recruited; yes/no), and length of time required for recruitment (were 76 participants recruited within six weeks; yes/no).

Hypothesis 2: An online nutrition education program for people with MS is practical to complete.
Practicality will be assessed by measuring time spent on each module (actual use) and participant completion (ability of participants to carry out the nutrition education program activities). The proportion of participants (%) that complete each module and participant retention for the entire program will be reported.

Hypothesis 3: An online nutrition education program for people with MS is acceptable to participants.
Acceptability of the program content will be assessed using the interest/enjoyment and the value/usefulness subscales of the IMI. The scores for each of the subscales will be reported.

Aim 2: To evaluate the efficacy of an online nutrition education program for people with MS

Hypothesis 4: An online nutrition education program for people with MS improves diet quality.
Hypothesis 5: An online nutrition education program for people with MS improves food and nutrition literacy.

We will use either a paired t-test or a paired samples Wilcoxon Test to determine differences to Diet Habits Questionnaire, Critical Nutrition Literacy Tool, and the Food Literacy Behaviour Checklist scores pre- and post-intervention. We will use generalized least squares regression to model the effect of time itself on changes in the overall score for diet quality, nutrition literacy, and food literacy pre- and post-intervention, as well as the effect of the intervention. Covariates in the analyses will include the information collected as part of the recruitment process (age, sex, type of MS, time since diagnosis, and education). Interactions will be explored and adjustments for multiple comparisons made where necessary. All data analysis will be conducted using Stata (version 14.3, StataCorp LLC, College Station, Texas, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2022
Actual
5/07/2022
Date of last participant enrolment
Anticipated
29/08/2022
Actual
14/08/2022
Date of last data collection
Anticipated
14/11/2022
Actual
13/12/2022
Sample size
Target
70
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310656 0
Charities/Societies/Foundations
Name [1] 310656 0
MS Australia
Country [1] 310656 0
Australia
Primary sponsor type
Individual
Name
Rebecca Russell
Address
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, Australia, 6845
Country
Australia
Secondary sponsor category [1] 311868 0
Individual
Name [1] 311868 0
Associate Professor Andrea Begley
Address [1] 311868 0
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, Australia, 6845
Country [1] 311868 0
Australia
Secondary sponsor category [2] 311869 0
Individual
Name [2] 311869 0
Associate Professor Lucinda Black
Address [2] 311869 0
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, Australia, 6845
Country [2] 311869 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310250 0
Curtin University Human Research Ethics Office
Ethics committee address [1] 310250 0
Research Office at Curtin
Curtin University
GPO Box U1987
Perth, Australia, 6845
Ethics committee country [1] 310250 0
Australia
Date submitted for ethics approval [1] 310250 0
01/12/2021
Approval date [1] 310250 0
13/01/2022
Ethics approval number [1] 310250 0
HRE2022-0020

Summary
Brief summary
Evidence suggests that making healthier food choices is beneficial for people with multiple sclerosis (MS), and making dietary changes can give people with MS a sense of control over their disease. People with MS often turn to the internet for information about diet, and are faced with conflicting information from the “special diets” promoted for MS. People with MS want clear information on what dietary changes to make, and how to make healthy food choices. To meet this need, we will develop and run an online nutrition education program for people with MS, using a variety of ways to present the information. The free six-week program will be co-designed with people with MS and MS health professionals, and will provide information on diet and MS, including: how diet might affect MS symptoms; gut health; foods to eat and avoid; meal-planning; dietary supplements; understanding scientific research; current and emerging research in diet and MS; and “special diets” promoted or sold for MS. We expect that completing the program will help people with MS make healthier food choices and improve their nutrition knowledge and skills. We will assess the suitability of the content, format, and duration of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117006 0
Mrs Rebecca Russell
Address 117006 0
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, WA, Australia 6485
Country 117006 0
Australia
Phone 117006 0
+61 892663160
Fax 117006 0
Email 117006 0
[email protected]
Contact person for public queries
Name 117007 0
Andrea Begley
Address 117007 0
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, WA, Australia 6485
Country 117007 0
Australia
Phone 117007 0
+61892662773
Fax 117007 0
Email 117007 0
[email protected]
Contact person for scientific queries
Name 117008 0
Andrea Begley
Address 117008 0
Curtin School of Population Health
Curtin University
GPO Box U1987
Perth, WA, Australia 6485
Country 117008 0
Australia
Phone 117008 0
+61892662773
Fax 117008 0
Email 117008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator; [email protected]


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.