Impact Program for Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impact of four week coaching program on dietary habits
Sponsored by

About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
All participants will be adults ages 18 to 65 diagnosed with any form of MS. Caregivers are also invited to attend the program if they would like to. No restrictions will be made based on sex, gender or other condition.
Exclusion Criteria:
- If the subjects are outside of the age range they will not be able to participate.
Sites / Locations
- UAB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coaching program
Arm Description
Participants will complete a 4-week coaching program in an on-line group setting. The purpose of the program will be to help participants change dietary behaviors via a small changes approach.
Outcomes
Primary Outcome Measures
Diet quality
Diet quality will be measured via 4 day food journal
Diet quality
Diet quality will be measured via 4 day food journal
Secondary Outcome Measures
Full Information
NCT ID
NCT05165238
First Posted
December 17, 2021
Last Updated
September 19, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05165238
Brief Title
Impact Program for Multiple Sclerosis
Official Title
Impact of a Four-Week Coaching Program on Dietary Habits in Adults With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore the effects of a four week diet coaching program on pain, fatigue, mood, and dietary habits among adults with multiple sclerosis.
Detailed Description
Multiple Sclerosis (MS) is the most common chronic disabling central nervous system (CNS) disease in young adults, affecting 1 in 1,000 people in Western countries. Disproportionate and unpredictable impacts of co-morbid health conditions enhances the needs for comprehensive MS management and wellness strategies.
However, comprehensive care is limited, forcing many people to neglect critical aspects of their wellness. This creates a profound need for health and wellness programs that provide education, connection, and activation.
Research shows a consistent need for more access to reliable information regarding symptoms, management, access to healthcare professionals, and rehabilitation. There is also a primary unmet need for more information on exercise, nutrition, insurance, transportation, and employment.
People living with MS often receive more information from advocacy organizations than their MS nurse or neurologist. Decreased access to healthcare professionals since the COVID-19 pandemic has heightened the need for credible information from organizations like Can Do MS. Over the past year, Can Do MS has seen significant growth in virtual program attendance, with participant identifying "learning new information" as a critical objective.
A multipronged approach utilizing auditory, visual, and kinesthetic learning styles is the preferred method for delivering information. There is also a need to appeal to multiple sensory channels through complimentary mediums (e.g. video, audio, written materials, tactile activities).
We will study the effects of the four week coaching program on dietary patterns in MS patients. This will be done through surveys the participants will complete through Qulatrics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching program
Arm Type
Experimental
Arm Description
Participants will complete a 4-week coaching program in an on-line group setting. The purpose of the program will be to help participants change dietary behaviors via a small changes approach.
Intervention Type
Behavioral
Intervention Name(s)
Impact of four week coaching program on dietary habits
Intervention Description
A registered dietitian will provide dietary coaching via online groups to participants.
Primary Outcome Measure Information:
Title
Diet quality
Description
Diet quality will be measured via 4 day food journal
Time Frame
end of intervention (4 weeks)
Title
Diet quality
Description
Diet quality will be measured via 4 day food journal
Time Frame
3 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All participants will be adults ages 18 to 65 diagnosed with any form of MS. Caregivers are also invited to attend the program if they would like to. No restrictions will be made based on sex, gender or other condition.
Exclusion Criteria:
If the subjects are outside of the age range they will not be able to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks Wingo, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35094
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact Program for Multiple Sclerosis
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