Autoimmun intervention Mastery Course Study (AIM)
Utvärdering av en onlinekurs utformad för att stödja antagandet av hälsosammare kost och egenvårdsrutiner hos patienter med multipel skleros
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52246
- Univeristy of Iowa
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention Autoimmune Intervention Mastery Course (AIM) online course
This arm will begin the intervention immediately after randomization |
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
Andra namn:
Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Andra namn:
|
|
Övrig: Delayed Autoimmune Intervention Mastery Course
This is the control arm. |
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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):
Tidsram: 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):
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Fatigue Impact Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline to 3 months
|
change in calcium intake, range 0 to 2000 mg |
baseline to 3 months
|
|
calcium intake
Tidsram: baseline to 6 months
|
change in calcium intake, range 0 to 2000 mg |
baseline to 6 months
|
|
Servings of whole grains consumed
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Terry L Wahls, MD, University of Iowa
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Titcomb 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Post-infektionssjukdomar
- Covid-19
- Muskuloskeletala sjukdomar
- Sjukdomar i nervsystemet
- Muskelsjukdomar
- Patologiska processer
- Neuromuskulära sjukdomar
- Kronisk sjukdom
- Sjukdomsegenskaper
- Reumatiska sjukdomar
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Luftvägsinfektioner
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Demyeliniserande autoimmuna sjukdomar, CNS
- Autoimmuna sjukdomar i nervsystemet
- Demyeliniserande sjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- Patologiska tillstånd, tecken och symtom
- Postakut covid-19 syndrom
- Multipel skleros
- Fibromyalgi
Andra studie-ID-nummer
- 202103542
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Will share study data to scientists with a published PROSPERO registered meta-analysis.
Tidsram för IPD-delning
A year after the data has been published.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .