Rouxbe Pilot for MS

April 25, 2019 updated by: Vijayshree Yadav, Oregon Health and Science University

A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Multiple Sclerosis Center.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of MS
  • Willingness to comply with the diet and values set forth in the course

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rouxbe
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.
Behavioral: Cooking Course
This is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
Time Frame: 6 months
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).
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight Change measured by body weight, body mass index, waist circumference
Time Frame: 6 months
6 months
Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
Time Frame: 6 months
6 months
Program Evaluation through Program Evaluation Survey
Time Frame: 6 months
6 months
Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Rouxbe Cooking School

Investigators

  • Principal Investigator: Vijayshree Yadav, MBBs, MCR, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00011383

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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