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Trial record 3 of 5 for:    glycemic | Multiple Sclerosis
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Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

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ClinicalTrials.gov Identifier: NCT03372187
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Brooks C. Wingo, PhD, University of Alabama at Birmingham

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: DIET-MS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All 20 participants will be placed into the intervention group.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DIET-MS
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Dietary adherence [ Time Frame: 1 year ]
    Assessed by number of dietary behavior changes made

  2. Physical activity adherence [ Time Frame: 1 year ]
    Assessed by number of physical activity behavior changes made


Secondary Outcome Measures :
  1. Feasibility of intervention implementation [ Time Frame: 1 year ]
    Assessed by number of sessions attended


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Relapsing-Remitting Multiple Sclerosis
  2. On disease modifying treatment for 6 months
  3. No relapse within the previous 30 days
  4. Self-identify as not currently meeting recommendations for healthy diet and physical activity
  5. Ambulatory with or without assistance
  6. Reliable access to the internet via computer or smartphone
  7. Be responsible for their personal food preparation or have input into the food prepared for them

Exclusion criteria

  1. Unstable cardiovascular disease
  2. Unstable renal disease
  3. Unstable pulmonary disease
  4. Physician does not approve participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372187


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Multiple Sclerosis Society
More Information
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Responsible Party: Brooks C. Wingo, PhD, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03372187    
Other Study ID Numbers: pending
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brooks C. Wingo, PhD, University of Alabama at Birmingham:
diet
MS
Telehealth
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases