Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
800g Challenge
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: age 18-70 years a self-reported diagnosis of multiple sclerosis relapse free in past 30 days non-pregnant willing and able to visit University of North Texas on two testing occasions Exclusion Criteria: electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
Sites / Locations
- University of North Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diet Intervention
Arm Description
8 week non-restrictive diet program
Outcomes
Primary Outcome Measures
Metabolic Health
Fasted Cholesterol and Gloucose
Body Weight
Change in Body Weight
Body Fat
Change in Body Fat Percentage
Secondary Outcome Measures
6-Minute Walk
Change in 6-Minute Walk Distance
25-Foot Walk
Change in 25-Foot Walk Speed
Cognitive Assessments
Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.
Fatigue
Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.
Health-Related Quality of Life
Change in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life.
Full Information
NCT ID
NCT05712408
First Posted
January 25, 2023
Last Updated
August 9, 2023
Sponsor
University of North Texas, Denton, TX
1. Study Identification
Unique Protocol Identification Number
NCT05712408
Brief Title
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Official Title
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
April 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Texas, Denton, TX
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 current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).
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
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet Intervention
Arm Type
Experimental
Arm Description
8 week non-restrictive diet program
Intervention Type
Behavioral
Intervention Name(s)
800g Challenge
Intervention Description
The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.
Primary Outcome Measure Information:
Title
Metabolic Health
Description
Fasted Cholesterol and Gloucose
Time Frame
From recruitment to end of 8 week intervention
Title
Body Weight
Description
Change in Body Weight
Time Frame
From recruitment to end of 8 week intervention
Title
Body Fat
Description
Change in Body Fat Percentage
Time Frame
From recruitment to end of 8 week intervention
Secondary Outcome Measure Information:
Title
6-Minute Walk
Description
Change in 6-Minute Walk Distance
Time Frame
From recruitment to end of 8 week intervention
Title
25-Foot Walk
Description
Change in 25-Foot Walk Speed
Time Frame
From recruitment to end of 8 week intervention
Title
Cognitive Assessments
Description
Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.
Time Frame
From recruitment to end of 8 week intervention
Title
Fatigue
Description
Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.
Time Frame
From recruitment to end of 8 week intervention
Title
Health-Related Quality of Life
Description
Change in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life.
Time Frame
From recruitment to end of 8 week intervention
Other Pre-specified Outcome Measures:
Title
Acceptability of Intervention
Description
Participants ratings of satisfaction with the diet program. Scores range from 1-5 with higher scores indicating greater satisfaction.
Time Frame
From recruitment to end of 8 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-70 years
a self-reported diagnosis of multiple sclerosis
relapse free in past 30 days
non-pregnant
willing and able to visit University of North Texas on two testing occasions
Exclusion Criteria:
electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Silveira
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Texas
City
Denton
State/Province
Texas
ZIP/Postal Code
76203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
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