Autoimmune Intervention Mastery Course Study (AIM)

July 10, 2023 updated by: Terry L. Wahls

Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients

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, and post acute sequela of covid

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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), clinically isolated syndrome (CIS), fibromyalgia, and post acute sequela of covid.

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • Recruiting
        • Univeristy of Iowa
        • Principal Investigator:
          • Terry Wahls, MD
        • Sub-Investigator:
          • Linda Snetselaar, PhD, RD
        • Contact:
        • Sub-Investigator:
          • John Kamholz, MD PhD
        • Sub-Investigator:
          • Tyler Titcomb, PhD RD
        • Sub-Investigator:
          • Babita Bisht, PhD PT
        • Sub-Investigator:
          • Patrick Ten Eyck, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • self-reported multiple sclerosis
  • self-reported clinically isolated syndrome

OR self-reported post-acute sequelae of COVID (PASC), also known as long COVID, with a confirmed laboratory test of COVID-19 infection, persisting fatigue and neuropsychiatric symptoms for longer than 6 months after confirmation of COVID diagnosis,

OR self-reported diagnosis of fibromyalgia as documented by their treating specialist or primary care provider,

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Autoimmune Intervention Mastery Course (AIM) online course
This arm will begin the intervention immediately after randomization
Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM)
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
Other Names:
  • AIM course
Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions)
Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Other Names:
  • AIM Q and A sessions
Other: Delayed Autoimmune Intervention Mastery Course
This is the control arm.
Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course)
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
Behavioral: Delayed AIM Question and Answer sessions
Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Other Names:
  • Delayed AIM Q and A sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Time Frame: baseline to 3 months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
baseline to 3 months
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Time Frame: baseline to 6months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
baseline to 6months
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Time Frame: baseline to 3 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
baseline to 3 months
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Time Frame: baseline to 6 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
baseline to 6 months
Short form 36 (SF 36)
Time Frame: baseline to 3 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
baseline to 3 months
Short form 36 (SF 36)
Time Frame: baseline to 6 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Fatigue Impact Scale
Time Frame: baseline to 3 months
Change in MFIS survey questions, scores range from 0-84, lower score is better.
baseline to 3 months
Modified Fatigue Impact Scale
Time Frame: baseline to 6 months
Change in MFIS survey questions, scores range from 0-84, lower score is better.
baseline to 6 months
vegetable and fruit intake
Time Frame: baseline to 3 months
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
baseline to 3 months
vegetable and fruit intake
Time Frame: baseline to 6 months
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
baseline to 6 months
added sugar intake
Time Frame: baseline to 3 months
change in the grams of added sugar consumed each day, grams range from 0 to 100
baseline to 3 months
added sugar intake
Time Frame: baseline to 6 months
change in the grams of added sugar consumed each day, grams range from 0 to 100
baseline to 6 months
calcium intake
Time Frame: baseline to 3 months
change in calcium intake, range 0 to 2000 mg
baseline to 3 months
calcium intake
Time Frame: baseline to 6 months
change in calcium intake, range 0 to 2000 mg
baseline to 6 months
Servings of whole grains consumed
Time Frame: baseline to 3 months
change in number of servings of whole grains consumed, range 0 to 6 or more servings
baseline to 3 months
Servings of whole grains consumed
Time Frame: baseline to 6 months
change in number of servings of whole grains consumed, range 0 to 6 or more servings
baseline to 6 months
Fibromyalgia Impact Questionnaire Revised
Time Frame: baseline to 3 months
Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact
baseline to 3 months
Fibromyalgia Impact Questionnaire Revised
Time Frame: baseline to 6 months
Pain Rating (0-10 Low to High Scale)15 items with higher score indicating greater impact
baseline to 6 months
Brief Pain Inventory
Time Frame: baseline to 3 months
Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity
baseline to 3 months
Brief Pain Inventory
Time Frame: baseline to 6 months
Range 0-10( Low to High Scale) with higher score indicating greater pain intensity
baseline to 6 months
FM Disease activity (FIQR)
Time Frame: baseline to 3 months
0-100( Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
baseline to 3 months
FM Disease activity (FIQR)
Time Frame: baseline to 6 months
0-100 (Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. High score indicating more severe symptoms.
baseline to 6 months
Pain scale
Time Frame: baseline to 3 months
0-10 (low to high) 13 items used to evaluate feelings about pain.
baseline to 3 months
Pain catastrophizing scale
Time Frame: baseline to 6 months
052 (low to high) 13 items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terry L. Wahls

Investigators

  • Principal Investigator: Terry L Wahls, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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