Autoimmune Intervention Mastery Course Study (AIM)

• ClinicalTrials.gov Identifier: NCT05057676
• Recruitment Status: Recruiting
• First Posted: September 27, 2021
• Last Update Posted: July 12, 2023
• Sponsor: Terry L. Wahls
• Information provided by (Responsible Party): Terry L. Wahls, University of Iowa

Study Description

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

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis; Clinically Isolated Syndrome; Fibromyalgia; Post Acute Sequelae of COVID-19	Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM); Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions); Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course); Behavioral: Delayed AIM Question and Answer sessions	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Wait list control
• Masking: Single (Investigator)
• Masking Description: Investigator will be masked.
• Primary Purpose: Supportive Care
• Official Title: Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: December 1, 2026
• Estimated Study Completion Date: December 1, 2026

Arms and Interventions

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 Name: 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 Name: AIM Q and A sessions
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 Name: Delayed AIM Q and A sessions

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Secondary Outcome Measures :

1. Modified Fatigue Impact Scale [ Time Frame: baseline to 3 months ]
   Change in MFIS survey questions, scores range from 0-84, lower score is better.
2. Modified Fatigue Impact Scale [ Time Frame: baseline to 6 months ]
   Change in MFIS survey questions, scores range from 0-84, lower score is better.
3. 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
4. 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
5. 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
6. 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
7. calcium intake [ Time Frame: baseline to 3 months ]
   change in calcium intake, range 0 to 2000 mg
8. calcium intake [ Time Frame: baseline to 6 months ]
   change in calcium intake, range 0 to 2000 mg
9. 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
10. 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
11. Fibromyalgia Impact Questionnaire Revised [ Time Frame: baseline to 3 months ]
    Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact
12. 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
13. Brief Pain Inventory [ Time Frame: baseline to 3 months ]
    Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity
14. Brief Pain Inventory [ Time Frame: baseline to 6 months ]
    Range 0-10( Low to High Scale) with higher score indicating greater pain intensity
15. 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.
16. 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.
17. Pain scale [ Time Frame: baseline to 3 months ]
    0-10 (low to high) 13 items used to evaluate feelings about pain.
18. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

-

Contacts and Locations

Contacts

Contact: Study Coordinator; 3193845002; MSDietStudy@healthcare.uiowa.edu

Locations

United States, Iowa

Univeristy of Iowa; Recruiting

Iowa City, Iowa, United States, 52246

Contact: Mary Ehlinger, BS 319-384-5002 mary-ehlinger@uiowa.edu

Sub-Investigator: Linda Snetselaar, PhD, RD

Sub-Investigator: John Kamholz, MD PhD

Principal Investigator: Terry Wahls, MD

Sub-Investigator: Tyler Titcomb, PhD RD

Sub-Investigator: Babita Bisht, PhD PT

Sub-Investigator: Patrick Ten Eyck, PhD

Sponsors and Collaborators

Terry L. Wahls

Investigators

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

More Information

Publications:

Wahls TL, Chenard CA, Snetselaar LG. Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic. Nutrients. 2019 Feb 7;11(2):352. doi: 10.3390/nu11020352.

Wahls T, Scott MO, Alshare Z, Rubenstein L, Darling W, Carr L, Smith K, Chenard CA, LaRocca N, Snetselaar L. Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial. Trials. 2018 Jun 4;19(1):309. doi: 10.1186/s13063-018-2680-x.

Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 1;11(3):537. doi: 10.3390/nu11030537.

Titcomb TJ, Bisht B, Moore DD 3rd, Chhonker YS, Murry DJ, Snetselaar LG, Wahls TL. Eating Pattern and Nutritional Risks among People with Multiple Sclerosis Following a Modified Paleolithic Diet. Nutrients. 2020 Jun 20;12(6):1844. doi: 10.3390/nu12061844.

Wahls TL, Titcomb TJ, Bisht B, Eyck PT, Rubenstein LM, Carr LJ, Darling WG, Hoth KF, Kamholz J, Snetselaar LG. Impact of the Swank and Wahls elimination dietary interventions on fatigue and quality of life in relapsing-remitting multiple sclerosis: The WAVES randomized parallel-arm clinical trial. Mult Scler J Exp Transl Clin. 2021 Jul 31;7(3):20552173211035399. doi: 10.1177/20552173211035399. eCollection 2021 Jul-Sep.

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 Mar 26.

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.

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.

Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.

• Responsible Party: Terry L. Wahls, Clinical professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT05057676
• Other Study ID Numbers: 202103542
• First Posted: September 27, 2021
• Last Update Posted: July 12, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Terry L. Wahls, University of Iowa:

diet; self care

Additional relevant MeSH terms:

Post-Acute COVID-19 Syndrome; Fibromyalgia; Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes