Autoimmune Intervention Mastery Course Study (AIM)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    80
  • sponsor
    Terry L. Wahls
Updated on 22 March 2022
clinically isolated syndrome

Summary

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) and clinically isolated syndrome (CIS).

Description

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) and clinically isolated syndrome (CIS).

Once eligibility criteria are determined and consent is obtained, participants would work through the course modules like a non-graded online course. There are exercises and personal assessments within the course participants are asked to take to build upon each other to increase the success of the experience while taking the course.

Throughout the course there will be modules that will discuss an inner game plan, food intervention plan, physical intervention plan, and an increased resilience plan. The fourth module suggests different strategies that participants can do to improve their health beyond food and exercise. These types of things would include supplements, light therapy, detoxification, improved sleep, stress reduction, and other ways to enhance their body's resilience.

Investigators ask that participants inform and work with their healthcare team to personalize their treatment and determine if the suggested strategies mentioned in the course are appropriate for their healthcare path. This will provide dietary education to a larger sample size compared to what has been studied in the past. The study may include more patients that have limited resources, including but not limited to, money and location for access to registered dietitians with expertise in dietary instruction for patient s diagnosed with multiple sclerosis and CIS. There is interest in education and support that can be delivered via an online platform that can lead to improved diet quality and self-care routines for multiple sclerosis and autoimmune patients.

This study will use a randomized single-blind wait list control design to evaluate the impact of an online course that teaches the modified Paleolithic diet, nutrient dense vegetarian diet and Mediterranean diets, stress reduction and exercise strategies using commercially available online course for autoimmune patients. Data will be collected in the short-term (after 3 months) and long-term (at the end of 6 months ) to analyze the impact of an online wellness program QoL and related outcomes among people with CIS and MS.

The study will use a 7-day window to collect baseline assessments. Participants will use a personal email that does not contain identifying information to participate in the study. Participants will be asked to complete all baseline assessments. This email and password will be used for access to the online course materials. Patients will be randomized to the intervention arm based upon the baseline modified fatigue impact score.

Patients will receive access to the online program and 7 group support videos (released one per week or 7 weeks total). Participants will access the course materials using the study assigned email.

The proposed study will consist of virtual-only participants and will have 3 virtual visits every 3 months (months 0, 3, and 6). Online questionnaires will be sent to the participants to assess fatigue and quality of life. Dietary assessments will include a questionnaire through a web-based tool after baseline, at month 3, and month 6.

Details
Condition Multiple Sclerosis, Clinically Isolated Syndrome
Treatment Immediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions), Delayed Autoimmune Intervention Mastery Course (delayed AIM course), Delayed AIM Question and Answer sessions
Clinical Study IdentifierNCT05057676
SponsorTerry L. Wahls
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

self-reported multiple sclerosis
self-reported clinically isolated syndrome

Exclusion Criteria

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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