Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Nutrition, Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Anne-Marie Wills, MD, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

NCT02418546

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital
Taylor 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 Hospital

Participant Duration:

The study treatment period is approximately 6 months and observation period is approximately 7 months.

Estimated Enrollment:

150

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    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

    Exclusion Criteria:
    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.

  • Site Contact Information

    Mass General Hospital
    Courtney Ortiz-Miller / .(JavaScript must be enabled to view this email address) / 617-643-2522
    Boston, Massachusetts 02114
    United States