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Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DIET-MS
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring diet, MS, Telehealth

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DIET-MS

Arm Description

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.

Outcomes

Primary Outcome Measures

Dietary adherence
Assessed by number of dietary behavior changes made
Physical activity adherence
Assessed by number of physical activity behavior changes made

Secondary Outcome Measures

Feasibility of intervention implementation
Assessed by number of sessions attended

Full Information

First Posted
November 17, 2017
Last Updated
March 20, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT03372187
Brief Title
Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Official Title
Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
diet, MS, Telehealth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All 20 participants will be placed into the intervention group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DIET-MS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DIET-MS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dietary adherence
Description
Assessed by number of dietary behavior changes made
Time Frame
1 year
Title
Physical activity adherence
Description
Assessed by number of physical activity behavior changes made
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Feasibility of intervention implementation
Description
Assessed by number of sessions attended
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

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