Online Wellness Program for Multiple Sclerosis

(DEW Trial)

ME
WS
Overseen ByWhitney Schley, Schley
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Iowa

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people aged 45 to 70 with progressive multiple sclerosis who are experiencing significant fatigue. Participants must be able to use online platforms and complete study activities.

Inclusion Criteria

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 capable of audio/video streaming and accessing online programming
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Exclusion Criteria

Measurement of Body Mass Index (BMI) less than 19
Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia)
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)
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What Are the Treatments Tested in This Trial?

Interventions

  • Online wellness course and online exercise platform

Trial Overview

The study compares an online wellness program—including self-paced courses, group coaching, and exercise resources—to usual care. Participants are randomly assigned to either start the program right away or after a 6-month wait period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention armExperimental Treatment1 Intervention
Group II: Waitlist controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+