Rouxbe Pilot for MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooking Course
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring diet, cooking, multiple sclerosis, fatigue
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of MS
- Willingness to comply with the diet and values set forth in the course
Sites / Locations
- Oregon Health & Science University Multiple Sclerosis Center.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rouxbe
Arm Description
Subjects will attend a one-month online cooking course, and be followed before, during, and after their participation for quality-of-life, fatigue, and blood biomarker changes.
Outcomes
Primary Outcome Measures
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
We will measure feasibility as a composite of student perception, learning, and adherence by administering Opening and Closing Surveys (to evaluate student perception of course), a Final Assessment (to evaluate student learning), and the NutritionQuest Block Food Frequency Questionnaire (to evaluate adherence to low-fat, plant-based lifestyle).
Secondary Outcome Measures
Weight Change measured by body weight, body mass index, waist circumference
Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
Program Evaluation through Program Evaluation Survey
Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
Full Information
NCT ID
NCT02424825
First Posted
February 9, 2015
Last Updated
April 25, 2019
Sponsor
Oregon Health and Science University
Collaborators
Rouxbe Cooking School
1. Study Identification
Unique Protocol Identification Number
NCT02424825
Brief Title
Rouxbe Pilot for MS
Official Title
A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Rouxbe Cooking School
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected.
This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
diet, cooking, multiple sclerosis, fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rouxbe
Arm Type
Experimental
Arm Description
Subjects will attend a one-month online cooking course, and be followed before, during, and after their participation for quality-of-life, fatigue, and blood biomarker changes.
Intervention Type
Behavioral
Intervention Name(s)
Cooking Course
Intervention Description
This is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet.
Primary Outcome Measure Information:
Title
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
Description
We will measure feasibility as a composite of student perception, learning, and adherence by administering Opening and Closing Surveys (to evaluate student perception of course), a Final Assessment (to evaluate student learning), and the NutritionQuest Block Food Frequency Questionnaire (to evaluate adherence to low-fat, plant-based lifestyle).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight Change measured by body weight, body mass index, waist circumference
Time Frame
6 months
Title
Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
Time Frame
6 months
Title
Program Evaluation through Program Evaluation Survey
Time Frame
6 months
Title
Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of MS
Willingness to comply with the diet and values set forth in the course
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijayshree Yadav, MBBs, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University Multiple Sclerosis Center.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Links:
URL
http://rouxbe.com/
Description
Rouxbe Cooking School
Learn more about this trial
Rouxbe Pilot for MS
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