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Auto-immuuninterventie Mastery Course Study (AIM)

15 september 2026 bijgewerkt door: Terry L. Wahls

Evaluatie van een online cursus die is ontworpen om de acceptatie van gezondere voeding en zelfzorgroutines bij multiple sclerosepatiënten te ondersteunen

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52246
        • Univeristy of Iowa

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 100 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Autoimmune Intervention Mastery Course (AIM) online course

This arm will begin the intervention immediately after randomization
Gedragsmatig: 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

Andere namen:
  • AIM cursus
Gedragsmatig: 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.

Andere namen:
  • AIM Q en A-sessies
Ander: Delayed Autoimmune Intervention Mastery Course

This is the control arm.
Gedragsmatig: 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

Gedragsmatig: 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.

Andere namen:
  • Vertraagde AIM Q- en A-sessies

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Tijdsspanne: baseline to 3 months

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)
Tijdsspanne: baseline to 6months

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)
Tijdsspanne: baseline to 3 months

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)
Tijdsspanne: baseline to 6 months

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)
Tijdsspanne: baseline to 3 months

Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
baseline to 3 months
Short form 36 (SF 36)
Tijdsspanne: baseline to 6 months

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):
Tijdsspanne: 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.
baseline to 3 months
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
Tijdsspanne: 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.
baseline to 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Modified Fatigue Impact Scale
Tijdsspanne: baseline to 3 months

Change in MFIS survey questions, scores range from 0-84, lower score is better.
baseline to 3 months
Modified Fatigue Impact Scale
Tijdsspanne: baseline to 6 months

Change in MFIS survey questions, scores range from 0-84, lower score is better.
baseline to 6 months
vegetable and fruit intake
Tijdsspanne: baseline to 3 months

Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
baseline to 3 months
vegetable and fruit intake
Tijdsspanne: baseline to 6 months

Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
baseline to 6 months
added sugar intake
Tijdsspanne: baseline to 3 months

change in the grams of added sugar consumed each day, grams range from 0 to 100
baseline to 3 months
added sugar intake
Tijdsspanne: baseline to 6 months

change in the grams of added sugar consumed each day, grams range from 0 to 100
baseline to 6 months
calcium intake
Tijdsspanne: baseline to 3 months

change in calcium intake, range 0 to 2000 mg
baseline to 3 months
calcium intake
Tijdsspanne: baseline to 6 months

change in calcium intake, range 0 to 2000 mg
baseline to 6 months
Servings of whole grains consumed
Tijdsspanne: baseline to 3 months

change in number of servings of whole grains consumed, range 0 to 6 or more servings
baseline to 3 months
Servings of whole grains consumed
Tijdsspanne: baseline to 6 months

change in number of servings of whole grains consumed, range 0 to 6 or more servings
baseline to 6 months
Fibromyalgia Impact Questionnaire Revised
Tijdsspanne: baseline to 3 months

Pain Rating (0-10 Low to High Scale) survey questions with higher score indicating greater impact
baseline to 3 months
Fibromyalgia Impact Questionnaire Revised
Tijdsspanne: baseline to 6 months

Pain Rating (0-10 Low to High Scale) survey with 15 items with higher score indicating greater impact
baseline to 6 months
Brief Pain Inventory
Tijdsspanne: baseline to 3 months

Interference (0-10 Low to High Scale) 15 survey items with higher score indicating greater intensity
baseline to 3 months
Brief Pain Inventory
Tijdsspanne: baseline to 6 months

Range 0-10(Low to High Scale) survey with higher score indicating greater pain intensity
baseline to 6 months
FM Disease activity (FIQR)
Tijdsspanne: baseline to 3 months

0-100( Low to High Scale)21 survey items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
baseline to 3 months
FM Disease activity (FIQR)
Tijdsspanne: baseline to 6 months

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.
baseline to 6 months
Pain scale
Tijdsspanne: baseline to 3 months

0-10 (low to high) 13 survey items used to evaluate feelings about pain.
baseline to 3 months
Pain catastrophizing scale
Tijdsspanne: baseline to 6 months

052 (low to high) 13 survey items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems
baseline to 6 months
Functional Assessment of Cancer Therapy - General (FACT-G)
Tijdsspanne: baseline to 3 months

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.
baseline to 3 months
Functional Assessment of Cancer Therapy - General (FACT-G)
Tijdsspanne: baseline to 6 months

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.
baseline to 6 months
Optional interview at study conclusion
Tijdsspanne: collected 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
collected at study conclusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Terry L. Wahls

Onderzoekers

  • Hoofdonderzoeker: Terry L Wahls, MD, University of Iowa

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2021

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

15 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

15 september 2021

Eerst geplaatst (Werkelijk)

27 september 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202103542

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Will share study data to scientists with a published PROSPERO registered meta-analysis.

IPD-tijdsbestek voor delen

A year after the data has been published.

IPD-toegangscriteria voor delen

Scientists with a published (in a peer reviewed journal) PROSPERO meta-analysis protocol who have contacted the PI with a copy of the published protocol, their address, phone number and specific data that is being requested. The PI will review the documents and if determined appropriate, the PI will then initiate an outgoing material data use agreement with the Division of Sponsored Programs at the University of Iowa who will then contact the requesting scientist. Once the date use agreement has been signed, the data will be shared according to the terms outlined in the data use agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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