NCT05374473

An Online Lifestyle Modification Course for People With Multiple Sclerosis

An Online Lifestyle Modification Course for People With MS: a Randomised Controlled Trial of Course Effectiveness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 945 (actual)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lifestyle factors are known to affect the progression of multiple sclerosis (MS). Studies of participants with MS attending an evidence-based lifestyle modification program, delivered via face-to-face workshops, have demonstrated improved mental and physical health, reduced relapse rate and improved quality of life over 3 years follow up, and that behaviour change was feasible and sustainable. However, the face-to-face modality of this educational intervention is resource intensive, and accessibility may be impeded by geography, cost, and MS-specific factors such as illness, fatigue, and disability. Furthermore, the COVID-19 pandemic has highlighted the unpredictable ability to travel and the importance of flexibility of health-related education. The Neuroepidemiology Unit at the University of Melbourne has developed the Multiple Sclerosis Online Course (MSOC) to deliver a widely accessible and user-friendly educational tool for people with MS. The course aims to deliver the best available evidence regarding lifestyle-related risk factors in the development and progression of MS and behaviour modification to improve health outcomes. Two forms of the course were developed: 1. an intervention course delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and 2. a standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks. A feasibility study involving the delivery of the intervention and standard-care course was conducted from April to June 2021. The study assessed the primary outcomes of attrition in both intervention and standard-care arm. Secondary outcomes assessed assessed learnability, accessibility, and desirability via a Likert scale follow-up survey. A qualitative analysis examining motivation, expectations and outcomes was also conducted. Tertiary outcomes assessed the completion of the baseline surveys, a requirement to enter the course. Based on the feasibility study, the investigators have modified recruitment strategies, functionality, and the community forum aspects of the course. Investigators now aim to test the effectiveness of the intervention arm of the course versus the standard-care arm in a larger randomised controlled trial. Objective: To prospectively examine whether an MS Online intervention course (intervention arm) can deliver an evidence-based educational intervention that results in behaviour change which can be sustained and translated into improved health outcomes for people with MS, and whether these effects are superior to the MS Online standard-care course (control arm). Participants who are 18 or older, diagnosed with multiple sclerosis by a doctor are welcome to join our study. The online course will run for 6 weeks. During this time, there are no formal assessments or minimum time investment required, which means participants are free to navigate the course as they see fit. Prior to commencing the study, participants will be asked fill-out a survey about their health (e.g., fatigue) and lifestyle (e.g., diet) and will be asked to fill this out again during the study.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle modification	Content in the intervention arm was adapted from an evidence-based lifestyle modification program for people with MS outlined in print previously presented in a face-to-face format. The integrated lifestyle modification program translates the research evidence regarding modification of lifestyle related risk factors and health outcomes based on a detailed review of the literature around modifiable lifestyle risk factors that may influence MS disease progression, as outlined in the book Overcoming Multiple Sclerosis: the 7-step recovery program.
BEHAVIORAL	Standard-care	Content in standard-care arm was adapted from MS-related websites

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-05-16
• Last updated: 2023-12-12

Locations

1 site across 1 country: Australia