AIM: Autoimmune Intervention Mastery Course Study
Study Details
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) and clinically isolated syndrome (CIS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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) and clinically isolated syndrome (CIS).
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Autoimmune Intervention Mastery Course (AIM) online course This arm will begin the intervention immediately after randomization |
Behavioral: 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
Other Names:
Behavioral: 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.
Other Names:
|
| Other: Delayed Autoimmune Intervention Mastery Course This is the control arm. |
Behavioral: 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
Behavioral: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [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) [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) [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) [baseline to 6 months]
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Secondary Outcome Measures
- Modified Fatigue Impact Scale [baseline to 3 months]
Change in MFIS survey questions, scores range from 0-84, lower score is better.
- Modified Fatigue Impact Scale [baseline to 6 months]
Change in MFIS survey questions, scores range from 0-84, lower score is better.
- vegetable and fruit intake [baseline to 3 months]
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
- vegetable and fruit intake [baseline to 6 months]
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
- added sugar intake [baseline to 3 months]
change in the grams of added sugar consumed each day, grams range from 0 to 100
- added sugar intake [baseline to 6 months]
change in the grams of added sugar consumed each day, grams range from 0 to 100
- calcium intake [baseline to 3 months]
change in calcium intake, range 0 to 2000 mg
- calcium intake [baseline to 6 months]
change in calcium intake, range 0 to 2000 mg
- Servings of whole grains consumed [baseline to 3 months]
change in number of servings of whole grains consumed, range 0 to 6 or more servings
- Servings of whole grains consumed [baseline to 6 months]
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Eligibility Criteria
Criteria
Inclusion Criteria:
-
self-reported multiple sclerosis
-
self-reported clinically isolated syndrome
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univeristy of Iowa | Iowa City | Iowa | United States | 52246 |
Sponsors and Collaborators
- Terry L. Wahls
Investigators
- Principal Investigator: Terry L Wahls, MD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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). pii: E537. doi: 10.3390/nu11030537.
- 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.
- Lee JE, Titcomb TJ, Bisht B, Rubenstein LM, Louison R, Wahls TL. A Modified MCT-Based Ketogenic Diet Increases Plasma β-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.
- 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). pii: E1844. doi: 10.3390/nu12061844.
- 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.
- 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). pii: E352. doi: 10.3390/nu11020352. Review.
- 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.
- 202103542