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

NCT02846558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-06-15

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ellen Mowry, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-06-30
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02846558 on ClinicalTrials.gov