Autoimmune Intervention Mastery Course Study

Multiple Sclerosis Clinical Trial

— AIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05057676
• Other study ID #: 202103542
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: Study Coordinator
• Phone: 3193845002
• Email: MSDietStudy[@]healthcare.uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Fibromyalgia
• Multiple Sclerosis
• Sclerosis

Intervention

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
• 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.
• 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
• 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.

Locations

Country	Name	City	State
United States	Univeristy of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Terry L. Wahls

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to 3 months
Primary	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.	baseline to 6months
Primary	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.	baseline to 3 months
Primary	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.	baseline to 6 months
Primary	Short form 36 (SF 36)	Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.	baseline to 3 months
Primary	Short form 36 (SF 36)	Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.	baseline to 6 months
Secondary	Modified Fatigue Impact Scale	Change in MFIS survey questions, scores range from 0-84, lower score is better.	baseline to 3 months
Secondary	Modified Fatigue Impact Scale	Change in MFIS survey questions, scores range from 0-84, lower score is better.	baseline to 6 months
Secondary	vegetable and fruit intake	Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more	baseline to 3 months
Secondary	vegetable and fruit intake	Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more	baseline to 6 months
Secondary	added sugar intake	change in the grams of added sugar consumed each day, grams range from 0 to 100	baseline to 3 months
Secondary	added sugar intake	change in the grams of added sugar consumed each day, grams range from 0 to 100	baseline to 6 months
Secondary	calcium intake	change in calcium intake, range 0 to 2000 mg	baseline to 3 months
Secondary	calcium intake	change in calcium intake, range 0 to 2000 mg	baseline to 6 months
Secondary	Servings of whole grains consumed	change in number of servings of whole grains consumed, range 0 to 6 or more servings	baseline to 3 months
Secondary	Servings of whole grains consumed	change in number of servings of whole grains consumed, range 0 to 6 or more servings	baseline to 6 months
Secondary	Fibromyalgia Impact Questionnaire Revised	Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact	baseline to 3 months
Secondary	Fibromyalgia Impact Questionnaire Revised	Pain Rating (0-10 Low to High Scale)15 items with higher score indicating greater impact	baseline to 6 months
Secondary	Brief Pain Inventory	Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity	baseline to 3 months
Secondary	Brief Pain Inventory	Range 0-10( Low to High Scale) with higher score indicating greater pain intensity	baseline to 6 months
Secondary	FM Disease activity (FIQR)	0-100( Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.	baseline to 3 months
Secondary	FM Disease activity (FIQR)	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
Secondary	Pain scale	0-10 (low to high) 13 items used to evaluate feelings about pain.	baseline to 3 months
Secondary	Pain catastrophizing scale	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