Multiple Sclerosis Clinical Trial
Official title:
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
NCT number | NCT02846558 |
Other study ID # | IRB00105123 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | July 2017 |
Verified date | May 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Body Mass Index (BMI) = 25 kg/m^2 for calorie restriction study - BMI < 25 kg/m^2, or = 25 kg/m^2 if participant was unwilling to enroll in calorie restriction study - Smartphone with the ability to download and use the LoseIt! application (calorie restriction only) - Smartphone with the ability to take and store photos (calorie timing only) Exclusion Criteria: - History of diabetes requiring medication - Currently pregnant or breastfeeding - History of an eating disorder - Currently taking warfarin - History of major surgery within past 3 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence | Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period. | Baseline and 6 months | |
Secondary | Body Mass Index (BMI) | Change in body mass index from baseline to 6 months. | Baseline and 6 months | |
Secondary | Weight Change | Change in participant weight over the 6-month study period | Baseline and 6 months | |
Secondary | Weight Change Among Adherent Participants | The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period. | Baseline and 6 months | |
Secondary | Functional Assessment in MS Score | The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants. | Baseline and 6 months | |
Secondary | Fatigue | The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants. | Baseline and 6 months | |
Secondary | Sleep Quality | The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates "poor" from "good" sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates "poor" quality sleep, while a score of 0-4 indicates "good" quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants. | Baseline and 6 months | |
Secondary | Self-esteem | The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants. | Baseline and 6 months |
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