Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)
Study Purpose:
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Nutrition , Biomarkers/ImagingStudy Status:
Not enrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Anne-Marie Wills, MD, Massachusetts General Hospital
Clinicaltrials.gov ID (11 digit #):
NCT02418546Neals Affiliated?
YesCoordinating Center Contact Information
Mass General HospitalTaylor Mezoian / .(JavaScript must be enabled to view this email address) / 617-643-0312
.(JavaScript must be enabled to view this email address) Boston, Massachusetts 02114 United States
Full Study Summary:
This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.
Study Sponsor:
Massachusetts General HospitalParticipant Duration:
The study treatment period is approximately 6 months and observation period is approximately 7 months.