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

NCT02846558 | Completed Results

• 1 other identifier: IRB00105123
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

calorie restriction; weight loss

Outcome Measures

Primary Outcomes (1)

• Adherence

  Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.

  Baseline and 6 months

Secondary Outcomes (7)

• 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

Study Arms (4)

Calorie Restriction - Frequent Patient Communication

EXPERIMENTAL

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.

Other: Frequent Patient Interaction; Device: LoseIt! Smartphone Application

Timing Restriction

EXPERIMENTAL

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.

Behavioral: Timing Restriction

Calorie Restriction - Communication Standard of Care

PLACEBO COMPARATOR

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.

Device: LoseIt! Smartphone Application

No Diet Change

NO INTERVENTION

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

Interventions

Frequent Patient Interaction OTHER

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

Calorie Restriction - Frequent Patient Communication

Timing Restriction BEHAVIORAL

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

Timing Restriction

LoseIt! Smartphone Application DEVICE

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.

Calorie Restriction - Communication Standard of Care; Calorie Restriction - Frequent Patient Communication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• 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.

  PMID: 32408153 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Weight Loss

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limited sample size; Participants were enrolled from one treatment center, limited to patients with relapsing-remitting subtype of MS on natalizumab treatments; Calorie and timing data were self-reported by participants.

Results Point of Contact

• Title: Dr. Ellen Mowry, M.D., M.C.R.
• Organization: Johns Hopkins Department of Neurology

emowry1@jhmi.edu

410-502-0675

Study Officials

• Ellen Mowry, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share