What this study is
The goal of this clinical trial is to learn if an online wellness program can lower fatigue and improve mood and quality of life in people with progressive multiple sclerosis who are 45 to 70 years old and are experiencing significant fatigue disability.
The main questions it aims to answer are:
- Does the online wellness program lower fatigue after 3 months and further lower fatigue after 6 months?
- Does the online wellness program improve anxiety, depression, and quality of life after 3 months and lead to additional improvements after 6 months? Researchers will compare participants who receive immediate access to the online wellness program with participants who continue their usual care and receive access to the program after the study ends.
Participants will:
- Complete online surveys at the start of the study, at 3 months, and at 6 months. Each survey session takes less than 1 hour.
- Complete a 7-day run-in period before randomization to confirm their interest and ability to complete study activities.
- Be assigned by chance to either the online wellness program group or the wait-list control group.
Participants in the online wellness program group will:
- Receive access to the "Creating Health" online course through the University of Iowa Canvas platform.
- Work through five self-paced education modules over 6 months. Topics include nutrition, stress management, and physical activity.
- Have access to monthly group coaching calls by Zoom.
- Have access to an online exercise platform.
- Have access to email and text support from the study team.
Participants in the wait-list control group will:
- Continue their usual diet, lifestyle, and medical care during the 6-month study period.
- Complete the same study surveys as the intervention group.
- Receive full access to the online wellness program, online exercise platform and support materials after completing their final 6-month surveys.
At the end of the study, all participants will complete final surveys about their symptoms, quality of life, and their experience with the program. Active study participation ends after the 6-month assessments are completed.
What's being tested
- Online wellness course and online exercise platform
Intervention · BEHAVIORAL
An online wellness course that teaches participants about behavior change, nutrition, exercise, stress management, and other wellness behaviors. Also includes access to an online exercise platform.
- Usual Care Group
Intervention · OTHER
Participant will continue with their usual diet and wellness behaviors.
Study details
- Official title
- Evaluation of an Online, On Demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis: A Randomized Waitlist Controlled Trial (DEW Study)
- Sponsor
- University of Iowa
- Conditions
- Primary Progressive Multiple Sclerosis (PPMS) · Secondary Progressive Multiple Sclerosis (SPMS)
- Enrolling
- 118 people
- Starts
- 2026-11-15
- Est. completion
- 2030-12-15
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Definitive diagnosis of Primary Progressive MS (PPMS) or Secondary Progressive MS (SPMS) based on the 2024 revised McDonald Criteria and confirmed by the treating neurologist who also approves participation.
- Age 45 to 70 at the time of consent.
- Must be fluent in both speaking and reading English. *Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.
- Fatigue Severity Scale (FSS) score of greater than or equal to 4.
- Ability to prepare, or availability of someone in the household to prepare, home-cooked meals.
- Willingness to commit to the study diet, 4-7-8 breathing technique, and a structured exercise program.
- Access to high-speed internet with ownership of a device that can access the online programming and is capable of audio/video streaming.
- Completion of online surveys at Month 0 (baseline), Month 3, & Month 6.
You can't join if
- Confirmation of taking insulin or coumadin.
- Documentation of relapse during the prior 4 weeks.
- Use of corticosteroids during the prior 4 weeks.
- Change or initiation of Disease Modifying Treatment (DMT) during the prior 4 weeks.
- Treatment for cancer by radiation or chemotherapy within the prior 12 months.
- Diagnosis of clinically significant heart, liver, or kidney disease, or history of oxalate kidney stones.
- Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia).
- Measurement of Body Mass Index (BMI) < 19.
- Initiation of or change in medication to treat mood disorders in the prior 12 weeks.
- Documentation of moderate or severe mental impairment (greater than or equal to 5 errors) as measured by the validated Short Portable Mental Health Questionnaire (SPMHQ).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUI Health Care
Iowa City, Iowa, United States
Study team
Sponsor
University of Iowa
Study ID 202602218
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.