Trials / Recruiting

RecruitingNCT05057676

Autoimmune Intervention Mastery Course Study

Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 400 (estimated)

Sponsor: Terry L. Wahls · Academic / Other
Sex: All
Age: 18 Years – 100 Years
Healthy volunteers: Not accepted

Summary

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, 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.

Conditions

Interventions

Type	Name	Description
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
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.
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.

Timeline

Start date: 2021-12-01
Primary completion: 2027-12-01
Completion: 2027-12-01
First posted: 2021-09-27
Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05057676. Inclusion in this directory is not an endorsement.