Autoimmune Intervention Mastery Course Study (AIM)
Primary Purpose
Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring diet, self care
Eligibility Criteria
Inclusion Criteria:
- self-reported multiple sclerosis
- self-reported clinically isolated syndrome
Exclusion Criteria:
-
Sites / Locations
- Univeristy of IowaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Autoimmune Intervention Mastery Course (AIM) online course
Delayed Autoimmune Intervention Mastery Course
Arm Description
This arm will begin the intervention immediately after randomization
This is the control arm.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Secondary Outcome Measures
Modified Fatigue Impact Scale
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Modified Fatigue Impact Scale
Change in MFIS survey questions, scores range from 0-84, lower score is better.
vegetable and fruit intake
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
vegetable and fruit intake
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
added sugar intake
change in the grams of added sugar consumed each day, grams range from 0 to 100
added sugar intake
change in the grams of added sugar consumed each day, grams range from 0 to 100
calcium intake
change in calcium intake, range 0 to 2000 mg
calcium intake
change in calcium intake, range 0 to 2000 mg
Servings of whole grains consumed
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Servings of whole grains consumed
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Fibromyalgia Impact Questionnaire Revised
Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact
Fibromyalgia Impact Questionnaire Revised
Pain Rating (0-10 Low to High Scale)15 items with higher score indicating greater impact
Brief Pain Inventory
Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity
Brief Pain Inventory
Range 0-10( Low to High Scale) with higher score indicating greater pain intensity
FM Disease activity (FIQR)
0-100( Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
FM Disease activity (FIQR)
0-100 (Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. High score indicating more severe symptoms.
Pain scale
0-10 (low to high) 13 items used to evaluate feelings about pain.
Pain catastrophizing scale
052 (low to high) 13 items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05057676
Brief Title
Autoimmune Intervention Mastery Course Study
Acronym
AIM
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Terry L. Wahls
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, and post acute sequela of covid
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, and post acute sequela of covid.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia, Post Acute Sequelae of COVID-19
Keywords
diet, self care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Wait list control
Masking
Investigator
Masking Description
Investigator will be masked.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Autoimmune Intervention Mastery Course (AIM) online course
Arm Type
Experimental
Arm Description
This arm will begin the intervention immediately after randomization
Arm Title
Delayed Autoimmune Intervention Mastery Course
Arm Type
Other
Arm Description
This is the control arm.
Intervention Type
Behavioral
Intervention Name(s)
Immediate Autoimmune Intervention Mastery Course (AIM)
Other Intervention Name(s)
AIM course
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Immediate Question and Answer sessions. (AIM Q and A sessions)
Other Intervention Name(s)
AIM Q and A sessions
Intervention Description
Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Autoimmune Intervention Mastery Course (delayed AIM course)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Delayed AIM Question and Answer sessions
Other Intervention Name(s)
Delayed AIM Q and A sessions
Intervention Description
Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Primary Outcome Measure Information:
Title
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Description
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 3 months
Title
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Description
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 6months
Title
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Description
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 3 months
Title
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Description
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 6 months
Title
Short form 36 (SF 36)
Description
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 3 months
Title
Short form 36 (SF 36)
Description
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale
Description
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time Frame
baseline to 3 months
Title
Modified Fatigue Impact Scale
Description
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time Frame
baseline to 6 months
Title
vegetable and fruit intake
Description
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Time Frame
baseline to 3 months
Title
vegetable and fruit intake
Description
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Time Frame
baseline to 6 months
Title
added sugar intake
Description
change in the grams of added sugar consumed each day, grams range from 0 to 100
Time Frame
baseline to 3 months
Title
added sugar intake
Description
change in the grams of added sugar consumed each day, grams range from 0 to 100
Time Frame
baseline to 6 months
Title
calcium intake
Description
change in calcium intake, range 0 to 2000 mg
Time Frame
baseline to 3 months
Title
calcium intake
Description
change in calcium intake, range 0 to 2000 mg
Time Frame
baseline to 6 months
Title
Servings of whole grains consumed
Description
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Time Frame
baseline to 3 months
Title
Servings of whole grains consumed
Description
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Time Frame
baseline to 6 months
Title
Fibromyalgia Impact Questionnaire Revised
Description
Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact
Time Frame
baseline to 3 months
Title
Fibromyalgia Impact Questionnaire Revised
Description
Pain Rating (0-10 Low to High Scale)15 items with higher score indicating greater impact
Time Frame
baseline to 6 months
Title
Brief Pain Inventory
Description
Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity
Time Frame
baseline to 3 months
Title
Brief Pain Inventory
Description
Range 0-10( Low to High Scale) with higher score indicating greater pain intensity
Time Frame
baseline to 6 months
Title
FM Disease activity (FIQR)
Description
0-100( Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
Time Frame
baseline to 3 months
Title
FM Disease activity (FIQR)
Description
0-100 (Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. High score indicating more severe symptoms.
Time Frame
baseline to 6 months
Title
Pain scale
Description
0-10 (low to high) 13 items used to evaluate feelings about pain.
Time Frame
baseline to 3 months
Title
Pain catastrophizing scale
Description
052 (low to high) 13 items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems
Time Frame
baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
3193845002
Email
MSDietStudy@healthcare.uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L Wahls, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ehlinger, BS
Phone
319-384-5002
Email
mary-ehlinger@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Linda Snetselaar, PhD, RD
First Name & Middle Initial & Last Name & Degree
John Kamholz, MD PhD
First Name & Middle Initial & Last Name & Degree
Terry Wahls, MD
First Name & Middle Initial & Last Name & Degree
Tyler Titcomb, PhD RD
First Name & Middle Initial & Last Name & Degree
Babita Bisht, PhD PT
First Name & Middle Initial & Last Name & Degree
Patrick Ten Eyck, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30736445
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.
Results Reference
background
PubMed Identifier
29866196
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.
Results Reference
background
PubMed Identifier
30832289
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.
Results Reference
background
PubMed Identifier
32575774
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.
Results Reference
background
PubMed Identifier
34377527
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.
Results Reference
background
PubMed Identifier
32213121
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.
Results Reference
background
PubMed Identifier
24476345
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.
Results Reference
background
PubMed Identifier
30050380
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.
Results Reference
background
PubMed Identifier
30050374
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.
Results Reference
background
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Autoimmune Intervention Mastery Course Study
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