Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis

Study Overview
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Brief Summary
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The current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).

Official Title
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Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: 800g Challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-70 years a self-reported diagnosis of multiple sclerosis relapse free in past 30 days non-pregnant willing and able to visit University of North Texas on two testing occasions Exclusion Criteria: electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Intervention<br>8 week non-restrictive diet program | Behavioral: 800g Challenge<br>* The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Health | Fasted Cholesterol and Gloucose | From recruitment to end of 8 week intervention | 
| Body Weight | Change in Body Weight | From recruitment to end of 8 week intervention | 
| Body Fat | Change in Body Fat Percentage | From recruitment to end of 8 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk | Change in 6-Minute Walk Distance | From recruitment to end of 8 week intervention | 
| 25-Foot Walk | Change in 25-Foot Walk Speed | From recruitment to end of 8 week intervention | 
| Cognitive Assessments | Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning. | From recruitment to end of 8 week intervention | 
| Fatigue | Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue. | From recruitment to end of 8 week intervention | 
| Health-Related Quality of Life | Change in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life. | From recruitment to end of 8 week intervention |