Autoimmune Intervention Mastery Course Study
AIM
Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Dec 2021
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 11, 2026
March 1, 2026
6 years
September 15, 2021
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
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
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
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
baseline to 3 months
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
baseline to 6 months
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.
baseline to 3 months
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.
baseline to 6 months
Secondary Outcomes (21)
Modified Fatigue Impact Scale
baseline to 3 months
Modified Fatigue Impact Scale
baseline to 6 months
vegetable and fruit intake
baseline to 3 months
vegetable and fruit intake
baseline to 6 months
added sugar intake
baseline to 3 months
- +16 more secondary outcomes
Study Arms (2)
Intervention Autoimmune Intervention Mastery Course (AIM) online course
EXPERIMENTALThis arm will begin the intervention immediately after randomization
Delayed Autoimmune Intervention Mastery Course
OTHERThis is the control arm.
Interventions
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 access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
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 access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Eligibility Criteria
You may qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Terry L. Wahlslead
Study Sites (1)
Univeristy of Iowa
Iowa City, Iowa, 52246, United States
Related Publications (10)
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.
PMID: 30736445BACKGROUNDWahls 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.
PMID: 29866196BACKGROUNDChenard 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.
PMID: 30832289BACKGROUNDTitcomb 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.
PMID: 32575774BACKGROUNDWahls 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.
PMID: 34377527BACKGROUNDLee 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.
PMID: 32213121BACKGROUNDBisht 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.
PMID: 24476345BACKGROUNDBisht 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.
PMID: 30050380BACKGROUNDIrish 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.
PMID: 30050374BACKGROUNDTitcomb TJ, Sherwood M, Ehlinger M, Saxby SM, Shemirani F, Eyck PT, Wahls TL, Snetselaar LG. Evaluation of a web-based program for the adoption of wellness behaviors to self-manage fatigue and improve quality of life among people with multiple sclerosis: A randomized waitlist-control trial. Mult Scler Relat Disord. 2023 Sep;77:104858. doi: 10.1016/j.msard.2023.104858. Epub 2023 Jun 27.
PMID: 37399671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry L Wahls, MD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigator will be masked.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 27, 2021
Study Start
December 1, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share