DEW
What it found
No result yet.
What was tested
Treatment tested
- Online wellness course and online exercise platform
Placebo or sham
- Usual Care Group
What it measured
Main measures
Fatigue Severity Scale (FSS) Score
Baseline to 3 months
FatigueQuality of life (reported by participants)
Other measures (13)
Fatigue Severity Scale (FSS) Score
Baseline to 6 months
FatigueQuality of life (reported by participants)Change in Modified Fatigue Impact Scale (MFIS) Score
Baseline to month 3 and month 6.
Thinking and memoryFatigueChange in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Physical Health Composite Score
Baseline to month 3 and month 6
Quality of life (reported by participants)Change in MSQOL-54 Mental Health Composite Score
Baseline to month 3 and month 6
Thinking and memoryQuality of life (reported by participants)Change in Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)
Baseline to month 3 and month 6
Mood and sleepQuality of life (reported by participants)Change in Hospital Anxiety and Depression Scale Depression Subscale (HADS-D) Score
Baseline to month 3 and month 6
Mood and sleepQuality of life (reported by participants)Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
Baseline to month 3 and month 6
Physical functionChange in Physical Activity Vital Sign (PAVS) Weekly Minutes of Moderate-to-Vigorous Physical Activity
Baseline to month 3 and month 6
Physical functionSafetyChange in Mediterranean Diet Adherence Screener (MEDAS-14) Score
Baseline to month 3 and month 6
Quality of life (reported by participants)Change in Paleolithic Diet Adherence Screener (PDAS-12) Score
Baseline to month 3 and month 6
Quality of life (reported by participants)
Who could take part
Progressive MS · 45 to 70
Inclusion Criteria: 1. 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. 2. Age 45 to 70 at the time of consent. 3. 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. 4. Fatigue Severity Scale (FSS) score of greater than or equal to 4. 5. Ability to prepare, or availability of someone in the household to prepare, home-cooked meals. 6. Willingness to commit to the study diet, 4-7-8 breathing technique, and a structured exercise program. 7. Access to high-speed internet with ownership of a device that can access the online programming and is capable of audio/video streaming. 8. Completion of online surveys at Month 0 (baseline), Month 3, \& Month 6. Exclusion Criteria: 1. Confirmation of taking insulin or coumadin. 2. Documentation of relapse during the prior 4 weeks. 3. Use of corticosteroids during the prior 4 weeks. 4. Change or initiation of Disease Modifying Treatment (DMT) during the prior 4 weeks. 5. Treatment for cancer by radiation or chemotherapy within the prior 12 months. 6. Diagnosis of clinically significant heart, liver, or kidney disease, or history of oxalate kidney stones. 7. Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia). 8. Measurement of Body Mass Index (BMI) \< 19. 9. Initiation of or change in medication to treat mood disorders in the prior 12 weeks. 10. 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).
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
Background
Titcomb TJ, Sherwood M, Ehlinger M, Saxby SM, Shemirani F, Eyck PT, Wahls TL, Snetselaar LG. Evaluation of a web-based program for the adoption of wellness behaviors to self-manage fatigue and improve quality of life among people with multiple sclerosis: A randomized waitlist-control trial. Mult Scler Relat Disord. 2023 Sep;77:104858. doi: 10.1016/j.msard.2023.104858. Epub 2023 Jun 27.Background
Elliott-Wherry AN, Lee JE, Pearlman AM, Wahls TL. The Wahls Behavior Change Model for Complex Chronic Diseases: A Clinician's Guide. Degener Neurol Neuromuscul Dis. 2022 Sep 9;12:111-125. doi: 10.2147/DNND.S370173. eCollection 2022.Background
Lee JE, Titcomb TJ, Bisht B, Rubenstein LM, Louison R, Wahls TL. A Modified MCT-Based Ketogenic Diet Increases Plasma beta-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study. J Am Coll Nutr. 2021 Jan;40(1):13-25. doi: 10.1080/07315724.2020.1734988. Epub 2020 MarBackground
Bisht B, Darling WG, White EC, White KA, Shivapour ET, Zimmerman MB, Wahls TL. Effects of a multimodal intervention on gait and balance of subjects with progressive multiple sclerosis: a prospective longitudinal pilot study. Degener Neurol Neuromuscul Dis. 2017 Jun 26;7:79-93. doi: 10.2147/DNND.S128872. eCollection 2017.Background
Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.Background
Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.Background
Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.Background
Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601.
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History
Started
Nov 2026
Main results due
Nov 2029
Finished
Dec 2030
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