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

A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis

Sponsors

Lead Sponsor: Johns Hopkins University

Source Johns Hopkins University
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.

Overall Status Completed
Start Date August 2016
Completion Date July 2017
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Adherence Baseline and 6 months
Secondary Outcome
Measure Time Frame
Body Mass Index (BMI) Baseline and 6 months
Weight Change Baseline and 6 months
Weight Change Among Adherent Participants Baseline and 6 months
Functional Assessment in MS Score Baseline and 6 months
Fatigue Baseline and 6 months
Sleep Quality Baseline and 6 months
Self-esteem Baseline and 6 months
Enrollment 54
Condition
Intervention

Intervention Type: Other

Intervention Name: Frequent Patient Interaction

Description: Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

Arm Group Label: Calorie Restriction - Frequent Patient Communication

Intervention Type: Behavioral

Intervention Name: Timing Restriction

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

Arm Group Label: Timing Restriction

Intervention Type: Device

Intervention Name: LoseIt! Smartphone Application

Description: 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.

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ellen Mowry, MD Principal Investigator Johns Hopkins University
Verification Date

May 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Calorie Restriction - Frequent Patient Communication

Type: Experimental

Description: 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.

Label: Timing Restriction

Type: Experimental

Description: 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.

Label: Calorie Restriction - Communication Standard of Care

Type: Placebo Comparator

Description: 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.

Label: No Diet Change

Type: No Intervention

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov