Multiple Sclerosis Clinical Trial
Official title:
A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis
NCT number | NCT02424825 |
Other study ID # | IRB00011383 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | May 2015 |
Verified date | April 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Confirmed diagnosis of MS - Willingness to comply with the diet and values set forth in the course |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University Multiple Sclerosis Center. | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Rouxbe Cooking School |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 6 months | |
Secondary | Weight Change measured by body weight, body mass index, waist circumference | 6 months | ||
Secondary | Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey | 6 months | ||
Secondary | Program Evaluation through Program Evaluation Survey | 6 months | ||
Secondary | Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale | 6 months |
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