CompletedNCT03372187Updated Mar 23, 2020

Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

An interventional study of DIET-MS in Multiple Sclerosis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 21 Years to 65 Years
Sex: All

Study 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 studied

Multiple Sclerosis

Browse trials for

Multiple Sclerosis 3,452

Keywords

diet
MS
Telehealth

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
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.
Behavioral: DIET-MS

Interventions

BehavioralDIET-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.

What researchers measure

Primary outcomes

Dietary adherence
Assessed by number of dietary behavior changes made
Time frame: 1 year
Physical activity adherence
Assessed by number of physical activity behavior changes made
Time frame: 1 year

Secondary outcomes

Feasibility of intervention implementation
Assessed by number of sessions attended
Time frame: 1 year

Study locations

1 site

University of Alabama at Birmingham
Birmingham, Alabama 35294, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03372187
Lead sponsor: University of Alabama at Birmingham
Collaborators: National Multiple Sclerosis Society
Responsible party: Brooks C. Wingo, PhD (Primary Investigator, University of Alabama at Birmingham) — Principal investigator
First posted: Dec 13, 2017
Start date: Mar 9, 2018
Primary completion: Jun 30, 2019
Completion: Dec 31, 2019
Last update: Mar 23, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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