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Rouxbe Pilot for MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooking Course
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring diet, cooking, multiple sclerosis, fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 9, 2015
Last Updated
April 25, 2019
Sponsor
Oregon Health and Science University
Collaborators
Rouxbe Cooking School
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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

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Rouxbe Pilot for MS

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