Clinical trial NCT05057676: Autoimmune Intervention Mastery Course Study
Official title: Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Clinically Isolated Syndrome
Fibromyalgia
Post Acute Sequelae of COVID-19
Cancer in Remission With Persisting Fatigue
Keywords: diet
self care
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Wait list control
Primary purpose: SUPPORTIVE_CARE

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, post acute sequela of covid, and cancer in remission with persisting fatigue.

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, post acute sequela of covid, and cancer in remissin with persisting fatigue. The cancer patients must be patients at the University of Iowa Holden Cancer Center.

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, fibromyalgia, post acute sequela of covid, and cancer in remission wiht persisting fatigue.

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.

Eligibility 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:

-

Primary outcomes:
measure: Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
timeFrame: baseline to 3 months
measure: Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
timeFrame: baseline to 6months
measure: Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
timeFrame: baseline to 3 months
measure: Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
timeFrame: baseline to 6 months
measure: Short form 36 (SF 36)
timeFrame: baseline to 3 months
measure: Short form 36 (SF 36)
timeFrame: baseline to 6 months
measure: The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
timeFrame: baseline to 3 months
measure: The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: baseline to 3 months
measure: Modified Fatigue Impact Scale
timeFrame: baseline to 6 months
measure: vegetable and fruit intake
timeFrame: baseline to 3 months
measure: vegetable and fruit intake
timeFrame: baseline to 6 months
measure: added sugar intake
timeFrame: baseline to 3 months
measure: added sugar intake
timeFrame: baseline to 6 months
measure: calcium intake
timeFrame: baseline to 3 months
measure: calcium intake
timeFrame: baseline to 6 months
measure: Servings of whole grains consumed
timeFrame: baseline to 3 months
measure: Servings of whole grains consumed
timeFrame: baseline to 6 months
measure: Fibromyalgia Impact Questionnaire Revised
timeFrame: baseline to 3 months
measure: Fibromyalgia Impact Questionnaire Revised
timeFrame: baseline to 6 months
measure: Brief Pain Inventory
timeFrame: baseline to 3 months
measure: Brief Pain Inventory
timeFrame: baseline to 6 months
measure: FM Disease activity (FIQR)
timeFrame: baseline to 3 months
measure: FM Disease activity (FIQR)
timeFrame: baseline to 6 months
measure: Pain scale
timeFrame: baseline to 3 months
measure: Pain catastrophizing scale
timeFrame: baseline to 6 months
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: baseline to 3 months
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Univeristy of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Terry L Wahls, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.