Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

NCT ID: NCT03372187

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All 20 participants will be placed into the intervention group.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DIET-MS

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Brooks C. Wingo, PhD

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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pending

Identifier Type: -

Identifier Source: org_study_id

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