Health TrialsbyHealthPanel

Autoimmune Intervention Mastery Course Study

ConditionsMultiple SclerosisClinically Isolated SyndromeFibromyalgiaPost Acute Sequelae of COVID-19Cancer in Remission With Persisting Fatigue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorTerry L. Wahls

About this trial

The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

self-reported multiple sclerosis

self-reported clinically isolated syndrome

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Immediate Autoimmune Intervention Mastery Course (AIM)

    Behavioral

    Immediate access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care

  • Immediate Question and Answer sessions. (AIM Q and A sessions)

    Behavioral

    Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.

  • Delayed Autoimmune Intervention Mastery Course (delayed AIM course)

    Behavioral

    Delayed access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care

  • Delayed AIM Question and Answer sessions

    Behavioral

    Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Intervention Autoimmune Intervention Mastery Course (AIM) online courseExperimental treatment 2 interventions
Group B: Delayed Autoimmune Intervention Mastery CourseOther 2 interventions

Trial outcomes

Primary outcomes

1

Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

Time frame
baseline to 3 months
2

Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

Time frame
baseline to 6months
3

Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

Time frame
baseline to 3 months
4

Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

Time frame
baseline to 6 months

Secondary outcomes

1

Modified Fatigue Impact Scale

Change in MFIS survey questions, scores range from 0-84, lower score is better.

Time frame
baseline to 3 months
2

Modified Fatigue Impact Scale

Change in MFIS survey questions, scores range from 0-84, lower score is better.

Time frame
baseline to 6 months
3

vegetable and fruit intake

Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more

Time frame
baseline to 3 months
4

vegetable and fruit intake

Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more

Time frame
baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Terry L. Wahls

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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