- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165238
Impact Program for Multiple Sclerosis
Impact of a Four-Week Coaching Program on Dietary Habits in Adults With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35094
- UAB
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coaching program
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.
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A registered dietitian will provide dietary coaching via online groups to participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet quality
Time Frame: end of intervention (4 weeks)
|
Diet quality will be measured via 4 day food journal
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end of intervention (4 weeks)
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Diet quality
Time Frame: 3 months post intervention
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Diet quality will be measured via 4 day food journal
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3 months post intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Brooks Wingo, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300008553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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