Skip to main content
OpenTrials
Completed

NCT Number: NCT03372187

Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  1. Feasibility of intervention implementation

    Time frame: 1 year

    Assessed by number of sessions attended

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.