Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

NCT03372187 | Completed

• 1 other identifier: pending
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

diet; MS; Telehealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Feasibility of intervention implementation

  1 year

Study Arms (1)

DIET-MS

EXPERIMENTAL

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

Interventions

DIET-MS 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.

DIET-MS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable cardiovascular disease
• Unstable renal disease
• Unstable pulmonary disease
• Physician does not approve participation

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: All 20 participants will be placed into the intervention group.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 13, 2017
• Study Start: March 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)