Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Nutrition, Biomarkers/Imaging
Study Status:Active, currently recruiting
Study Chair(s)/Principal Investigator(s):
Anne-Marie Wills, MD, Massachusetts General Hospital
Clinicaltrials.gov ID (11 digit #):NCT02418546
Coordinating Center Contact InformationMass General Hospital
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 Hospital
The study treatment period is approximately 6 months and observation period is approximately 7 months.
Estimated Study Start Date:03/31/2015
Estimated Study Completion Date:11/30/2016
Posting Last Modified Date:01/31/2016
Date Study Added to alsconsortium.org:06/16/2015
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?Yes
1. Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
2. Male or female subjects aged 18 years or older.
3. Participants must be capable of providing informed consent and complying with trial procedures.
4. Participants must have an MGH swallowing screening tool score>5 at the time of the screening visit
5. Participants or a designated caregiver must be able to obtain home weights and communicate to their RD
1. Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
2. BMI>35 or history of diabetes.
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