A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846558
• Other study ID #: IRB00105123
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.

Description:

MS affects at least 400,000 people in the US alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. Recent research suggests that diet may be a critical factor in the development of MS. The "Western diet", high in sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism.

Studying patients with MS who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification represents an interesting potential therapy for MS, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. In addition to these direct effects, weight optimization may lead to improvements in MS-related symptoms, like fatigue, and overall quality of life.

This is a single-blinded randomized trial of adherence to a dietary intervention in patients with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of technology may help patients with MS adhere to a calorie restricted diet. It will also evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Frequent Patient Interaction
Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

Behavioral:
• Timing Restriction
Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.

Device:
• LoseIt! Smartphone Application
Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

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