|Study Title:||An online lifestyle modification course for people with Multiple Sclerosis: A Randomised Controlled Trial of Course Effectiveness|
|Rationale:||Increasing evidence in the scientific literature suggests that lifestyle modification could be a point of intervention for improving quality of life and clinical outcomes in people with MS. However, findings in the literature are conflicted and emphasise there is need for a randomised controlled trial to directly identify any causal associations between lifestyle factors and health outcomes. Thus,In the Neuroepidemiology Unit at the University of Melbourne we have developed the Multiple Sclerosis Online Course (MSOC) that will deliver the relevant information to people with MS that has the potential to improve their health outcomes.|
|Study Description:||The Multiple Sclerosis Online Course (MSOC) conducts a randomised controlled trial (RCT) to test the effectiveness of an intervention providing information on MS-related lifestyle behaviour in the form of an online course that was developed by researchers from the Neuroepidemiology Unit (NEU) at the University of Melbourne in modifying participant’s behaviour and improving health outcomes in people with MS. The control arm consists of an online course providing general MS-related material that was also developed by the NEU. The online-course will be delivered for 6 weeks in English, starts in April - June 2022.
The research will be carried out in the University of Melbourne, Australia.
The location at which the research is to be undertaken is Online.
Two groups of the MSOC will be developed with the aim of conducting a randomised control trial: (1) standard-care group and (2) intervention group. Both groups are identical in format and template designs. Each group is delivered in 7 modules over 6 weeks: introduction and overview of MS, diet, physical activity, sunlight and vitamin D, stress reduction, family and conclusion. The intervention and standard-care groups differ in content. Content in the intervention group was adapted from an evidence-based lifestyle modification program and research findings. the content of the standard-care course will be populated with information collected from a multitude of MS society websites from around the world, such as MS Australia, the National MS Society etc.
The intervention course will be made available to public for free when the MSOC study finish.For recruitment, details of the proposed study will be published on MS society websites through Australia, NZ, USA, UK, and Canada. The same information will be posted on Facebook page, available to people with MS and MS social groups worldwide. Participants can join the study via the link to the study website.
Participants will be required to:
(1) answer an online baseline survey of lifestyle and health questions
(2) participate a 6-week free online course
(3) answer an online 6-month follow-up survey of lifestyle and health questions
(4) answer an online 12-month follow-up survey of lifestyle and health questions
(5) answer an online 2.5-year follow-up survey of lifestyle and health questions
(6) participate a qualitative interview (with option to decline).
Results of the study will be provided to participants via email, website (study website and university website) and social media (Facebook and Twitter). The outcomes of the research will be made public via lay summary, presentation (conferences, seminars), and research publications (academic journal, discussion papers and reports).
|Recruitment Dates:||2022-01-31 to 2022-06-30|
|Who can participate:||Eligible participants must:
1. Be able to read, write, and speak English.
2. Be 18 years old or over.
3. Have a confirmed diagnosis of relapsing-remitting MS (by a neurologist).
4. Be able to access the internet and be able to view sessions.
|Location of Trial:||University of Melbourne|
|Trial Investigator:||Asso.Prof. Sandra Neate|
|Contact Information:||Asso.Prof. Sandra Neate