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

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ClinicalTrials.gov Identifier: NCT02846558
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE July 27, 2016
Results First Submitted Date  ICMJE April 13, 2018
Results First Posted Date  ICMJE June 15, 2018
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE August 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
Adherence [ Time Frame: Baseline and 6 months ]
Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • Weight Loss [ Time Frame: 6 months ]
    For patients in the calorie restriction arms, measurement of change in waist circumference.
  • Metabolism Biomarkers [ Time Frame: 6 months ]
    For patients in the timing restriction arm, assessment of any changes in metabolic biomarkers before and after the intervention.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Body Mass Index (BMI) [ Time Frame: Baseline and 6 months ]
    Change in body mass index from baseline to 6 months.
  • Weight Change [ Time Frame: Baseline and 6 months ]
    Change in participant weight over the 6-month study period
  • Weight Change Among Adherent Participants [ Time Frame: Baseline and 6 months ]
    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.
  • Functional Assessment in MS Score [ Time Frame: Baseline and 6 months ]
    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.
  • Fatigue [ Time Frame: Baseline and 6 months ]
    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.
  • Sleep Quality [ Time Frame: Baseline and 6 months ]
    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.
  • Self-esteem [ Time Frame: Baseline and 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • Health-related quality of life [ Time Frame: 6 months ]
    Changes in self-reported measure of quality of life.
  • Fatigue [ Time Frame: 6 months ]
    Changes in self-reported measures of fatigue
  • Sleep [ Time Frame: 6 months ]
    Changes in self-reported quantity and quality of sleep
  • BMI [ Time Frame: 6 months ]
    Change in weight and body mass index.
  • Self-esteem [ Time Frame: 6 months ]
    Changes in self-reported levels of self-esteem
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
Official Title  ICMJE A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Calorie Restriction - Frequent Patient Communication
    MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.
    Interventions:
    • Other: Frequent Patient Interaction
    • Device: LoseIt! Smartphone Application
  • Experimental: Timing Restriction
    MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.
    Intervention: Behavioral: Timing Restriction
  • Placebo Comparator: Calorie Restriction - Communication Standard of Care
    MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.
    Intervention: Device: LoseIt! Smartphone Application
  • No Intervention: No Diet Change
    MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index < 25 kg/m^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm
Publications * Roman SN, Fitzgerald KC, Beier M, Mowry EM. Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis. Mult Scler Relat Disord. 2020 Jul;42:102149. doi: 10.1016/j.msard.2020.102149. Epub 2020 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2016)
120
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02846558
Other Study ID Numbers  ICMJE IRB00105123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant's data will not be shared
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ellen Mowry, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP