NCT Number: NCT05057676
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52246, United States
Location status: Recruiting
Farnoosh Shemirani, PhD
SUB_INVESTIGATOR
Linda Snetselaar, PhD, RD
SUB_INVESTIGATOR
Mary Ehlinger, BS
CONTACT
Patrick Ten Eyck, PhD
SUB_INVESTIGATOR
Terry Wahls, MD
PRINCIPAL_INVESTIGATOR
Tyler Titcomb, PhD RD
SUB_INVESTIGATOR
Whitney Schley, BA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
-
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: AIM course
Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
Other names: AIM Q and A sessions
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.
Other names: Delayed AIM Q and A sessions
Time frame: baseline to 3 months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
Time frame: baseline to 6months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
Time frame: baseline to 3 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Time frame: baseline to 6 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Time frame: baseline to 3 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Time frame: baseline to 6 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
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.
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.
Time frame: baseline to 3 months
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: baseline to 6 months
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: baseline to 3 months
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Time frame: baseline to 6 months
Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more
Time frame: baseline to 3 months
change in the grams of added sugar consumed each day, grams range from 0 to 100
Time frame: baseline to 6 months
change in the grams of added sugar consumed each day, grams range from 0 to 100
Time frame: baseline to 3 months
change in calcium intake, range 0 to 2000 mg
Time frame: baseline to 6 months
change in calcium intake, range 0 to 2000 mg
Time frame: baseline to 3 months
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Time frame: baseline to 6 months
change in number of servings of whole grains consumed, range 0 to 6 or more servings
Time frame: baseline to 3 months
Pain Rating (0-10 Low to High Scale) survey questions with higher score indicating greater impact
Time frame: baseline to 6 months
Pain Rating (0-10 Low to High Scale) survey with 15 items with higher score indicating greater impact
Time frame: baseline to 3 months
Interference (0-10 Low to High Scale) 15 survey items with higher score indicating greater intensity
Time frame: baseline to 6 months
Range 0-10(Low to High Scale) survey with higher score indicating greater pain intensity
Time frame: 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.
Time frame: 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.
Time frame: baseline to 3 months
0-10 (low to high) 13 survey items used to evaluate feelings about pain.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Terry L. Wahls
Other
Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
Acronym: AIM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03759522
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Birmingham, Alabama, United States
View Trial DetailsNCT05901259
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Bergshamra, Stockholm County, Sweden
View Trial DetailsNCT04806620
ARFID, Ankylosing Spondylitis (AS)
Delafield, Wisconsin, United States
View Trial DetailsNCT07132775
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Chicago, Illinois, United States
View Trial Details