Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

Multiple Sclerosis Clinical Trial

Official title:

Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372187
• Other study ID #: pending
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary adherence	Assessed by number of dietary behavior changes made	1 year
Primary	Physical activity adherence	Assessed by number of physical activity behavior changes made	1 year
Secondary	Feasibility of intervention implementation	Assessed by number of sessions attended	1 year