Multiple SclerosisAIMNCT05057676
Autoimmune Intervention Mastery Course Study
A study testing Immediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions) and Delayed Autoimmune Intervention Mastery Course (delayed AIM course) in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Terry L. Wahls at 1 site in United States.
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, post acute sequela of covid, and cancer in remission with persisting fatigue. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia
- What is being tested?
- Immediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions) and Delayed Autoimmune Intervention Mastery Course (delayed AIM course)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, post acute sequela of covid, and cancer in remission with persisting fatigue.
Read the 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.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia, Post Acute Sequelae of COVID-19, Cancer in Remission With Persisting Fatigue
- Being tested
- Immediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions), Delayed Autoimmune Intervention Mastery Course (delayed AIM course), Delayed AIM Question and Answer sessions
- Keywords
- diet, self care
- Medical subject headings
- Multiple Sclerosis, Fibromyalgia, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Autoimmune Intervention Mastery Course (AIM)Behavioural
Also called AIM course
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)Behavioural
Also called 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)Behavioural
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 sessionsBehavioural
Also called Delayed AIM Q and A sessions
Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Autoimmune Intervention Mastery Course (AIM) online course | Experimental | This arm will begin the intervention immediately after randomization Receives: Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM); Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions) |
| Delayed Autoimmune Intervention Mastery Course | Other | This is the control arm. Receives: Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course); Behavioral: Delayed AIM Question and Answer sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 6 months
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Measured: baseline to 3 months
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Measured: 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.
Measured: 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.
Measured: baseline to 6 months
Secondary outcomes (21)
Modified Fatigue Impact Scale
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 3 months
Modified Fatigue Impact Scale
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: baseline to 6 months
vegetable and fruit intake
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Measured: baseline to 3 months
vegetable and fruit intake
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Measured: baseline to 6 months
added sugar intake
change in the grams of added sugar consumed each day, grams range from 0 to 100
Measured: baseline to 3 months
added sugar intake
change in the grams of added sugar consumed each day, grams range from 0 to 100
Measured: baseline to 6 months
calcium intake
change in calcium intake, range 0 to 2000 mg
Measured: baseline to 3 months
calcium intake
change in calcium intake, range 0 to 2000 mg
Measured: baseline to 6 months
Servings of whole grains consumed
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Measured: baseline to 3 months
Servings of whole grains consumed
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Measured: baseline to 6 months
Fibromyalgia Impact Questionnaire Revised
Pain Rating (0-10 Low to High Scale) survey questions with higher score indicating greater impact
Measured: baseline to 3 months
Fibromyalgia Impact Questionnaire Revised
Pain Rating (0-10 Low to High Scale) survey with 15 items with higher score indicating greater impact
Measured: baseline to 6 months
Brief Pain Inventory
Interference (0-10 Low to High Scale) 15 survey items with higher score indicating greater intensity
Measured: baseline to 3 months
Brief Pain Inventory
Range 0-10(Low to High Scale) survey with higher score indicating greater pain intensity
Measured: baseline to 6 months
FM Disease activity (FIQR)
0-100( Low to High Scale)21 survey items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
Measured: baseline to 3 months
FM Disease activity (FIQR)
0-100 (Low to High Scale)21 survey items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. High score indicating more severe symptoms.
Measured: baseline to 6 months
Pain scale
0-10 (low to high) 13 survey items used to evaluate feelings about pain.
Measured: baseline to 3 months
Pain catastrophizing scale
052 (low to high) 13 survey items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems
Measured: baseline to 6 months
Functional Assessment of Cancer Therapy - General (FACT-G)
measures health-related QoL covering 5 domains: physical well-being (7 items), family/social well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and fatigue-specific items (13 items).10 These items are scored on a 5-point Likert scale, where 0 = "not at all" and 5 = "very much," with a recall period over the past 7 days. Domain scores can be calculated by summing the scores for each domain, and/or a total score by summing the scores for all domains, with higher scores representing better functioning. General guidelines estimate for the FACT-G minimally important difference (MID), is 4-7 points. The total score ranges from 0-108.
Measured: baseline to 3 months
Functional Assessment of Cancer Therapy - General (FACT-G)
measures health-related QoL covering 5 domains: physical well-being (7 items), family/social well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and fatigue-specific items (13 items).10 These items are scored on a 5-point Likert scale, where 0 = "not at all" and 5 = "very much," with a recall period over the past 7 days. Domain scores can be calculated by summing the scores for each domain, and/or a total score by summing the scores for all domains, with higher scores representing better functioning. General guidelines estimate for the FACT-G minimally important difference (MID), is 4-7 points. The total score ranges from 0-108.
Measured: baseline to 6 months
Optional interview at study conclusion
Asking open ended questions about the participant's study experience, barriers, challenges, web-based aspect of course, social support, geographic location, experience with specific modules and suggestions for improvement for the course and the study
Measured: collected at study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Wait list control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057676
- Sponsor's protocol ID
- 202103542
- Acronym
- AIM
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share study data to scientists with a published PROSPERO registered meta-analysis.
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.
PubMed 30736445Wahls 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.
PubMed 29866196Chenard 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.
PubMed 30832289Titcomb 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.
PubMed 32575774Wahls 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.
PubMed 34377527Lee 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.
PubMed 32213121Bisht 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.
PubMed 24476345Bisht 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.
PubMed 30050380Irish 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.
PubMed 30050374Titcomb 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.
PubMed 37399671
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05057676
- Acronym / sponsor ID
- AIM / 202103542
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia, Post Acute Sequelae of COVID-19, Cancer in Remission With Persisting Fatigue
- Keywords
- diet, self care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Wait list control
| Arm | Type | Receives |
|---|---|---|
| Intervention Autoimmune Intervention Mastery Course (AIM) online course | Experimental | Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM), Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions)This arm will begin the intervention immediately after randomization |
| Delayed Autoimmune Intervention Mastery Course | Other | Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course), Behavioral: Delayed AIM Question and Answer sessionsThis is the control arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Autoimmune Intervention Mastery Course (AIM)Also: AIM courseImmediate 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 | Behavioural | Intervention Autoimmune Intervention Mastery Course (AIM) online course |
| Immediate Question and Answer sessions. (AIM Q and A sessions)Also: AIM Q and A sessionsImmediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total. | Behavioural | Intervention Autoimmune Intervention Mastery Course (AIM) online course |
| 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 | Behavioural | Delayed Autoimmune Intervention Mastery Course |
| Delayed AIM Question and Answer sessionsAlso: Delayed AIM Q and A sessionsDelayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total. | Behavioural | Delayed Autoimmune Intervention Mastery Course |
Primary outcome
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.
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.
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.
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.
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.
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.
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
Time frame: baseline to 3 months
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.
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
Time frame: baseline to 6 months
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.
21 secondary outcomes
Modified Fatigue Impact Scale
Time frame: baseline to 3 months
Modified Fatigue Impact Scale
Time frame: baseline to 6 months
vegetable and fruit intake
Time frame: baseline to 3 months
vegetable and fruit intake
Time frame: baseline to 6 months
added sugar intake
Time frame: baseline to 3 months
added sugar intake
Time frame: baseline to 6 months
calcium intake
Time frame: baseline to 3 months
calcium intake
Time frame: baseline to 6 months
Servings of whole grains consumed
Time frame: baseline to 3 months
Servings of whole grains consumed
Time frame: baseline to 6 months
Fibromyalgia Impact Questionnaire Revised
Time frame: baseline to 3 months
Fibromyalgia Impact Questionnaire Revised
Time frame: baseline to 6 months
Brief Pain Inventory
Time frame: baseline to 3 months
Brief Pain Inventory
Time frame: baseline to 6 months
FM Disease activity (FIQR)
Time frame: baseline to 3 months
FM Disease activity (FIQR)
Time frame: baseline to 6 months
Pain scale
Time frame: baseline to 3 months
Pain catastrophizing scale
Time frame: baseline to 6 months
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: baseline to 3 months
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: baseline to 6 months
Optional interview at study conclusion
Time frame: collected at study conclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 30736445Wahls 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.
- Background: PubMed 29866196Wahls 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.
- Background: PubMed 30832289Chenard 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.
- Background: PubMed 32575774Titcomb 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.
- Background: PubMed 34377527Wahls 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.
- Background: PubMed 32213121Lee 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.
- Background: PubMed 24476345Bisht 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.
- Background: PubMed 30050380Bisht 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.
- Background: PubMed 30050374Irish 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.
- Derived from this study: PubMed 37399671Titcomb 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.
- Individual participant dataSharing planned: Yes. Will share study data to scientists with a published PROSPERO registered meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Wahls, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions) and Delayed Autoimmune Intervention Mastery Course (delayed AIM course) in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Terry L. Wahls at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) (time frame: baseline to 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057676, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.