Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

Study Overview
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Brief Summary
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This project aims to determine the feasibility of delivering a comprehensive behavioral lifestyle intervention including dietary and exercise components via an evidence based, internet-delivered telehealth coaching platform. Further, investigators will gather preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic risk factors after participation in the intervention. The outcomes will inform the design of a larger randomized controlled trial.

Official Title
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Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: DIET-MS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Relapsing-Remitting Multiple Sclerosis On disease modifying treatment for 6 months No relapse within the previous 30 days Self-identify as not currently meeting recommendations for healthy diet and physical activity Ambulatory with or without assistance Reliable access to the internet via computer or smartphone Be responsible for their personal food preparation or have input into the food prepared for them Exclusion criteria Unstable cardiovascular disease Unstable renal disease Unstable pulmonary disease Physician does not approve participation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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
Interventional Model Description: All 20 participants will be placed into the intervention group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIET-MS<br>This group will follow a low glycemic load diet plan prescribed to them by a health coach and will receive information on exercise as well. This group will have weekly calls with the telehealth coach and will be provided access to the eHealth platform. | Behavioral: DIET-MS<br>* Following the completion of testing, all 20 participants will be placed into the DIET-MS group and will follow the prescribed diet plan for 12 weeks. At the end of the 12 weeks, the participants will return to complete follow up testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary adherence | Assessed by number of dietary behavior changes made | 1 year | 
| Physical activity adherence | Assessed by number of physical activity behavior changes made | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention implementation | Assessed by number of sessions attended | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, MS, Telehealth