The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)

Study Purpose:

This is phase IIa feasibility and tolerability study of a mobile health (mHealth) application designed to study the effects of remote dietary counseling on disease progression and quality of life. The study will consist of two phases: Part I will consist of building and beta-testing the ALS Nutrition app and Part II will consist of enrolling a larger cohort of users into the app.

Disease:

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

Study Type:

Observational Study

Study Category:

Device

Study Status:

Not yet enrolling

Phase:

Not Applicable

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

Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

NCT04051333

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
Mansi Sharma / .(JavaScript must be enabled to view this email address) / 617-643-2400
.(JavaScript must be enabled to view this email address) Boston, Massachusetts United States

Full Study Summary:

The investigators' prior work has shown that nutrition is an important modifiable prognostic factor for ALS disease progression and survival. In the recently completed E-Health Application To Measure Outcomes Remotely (EAT MORE) clinical trial (sponsored by the ALS Association), the investigators found that nutritional counseling supported by a mobile health (mHealth) app was associated with 0.5 points/month slower ALSFRS-R progression (p=0.17) and improved quality of life (p=0.09).

The investigators are now designing an ALS-specific app that can be used by everyone with ALS, including those who do not live near ALS Centers. The app would help to address gaps in the delivery of ALS care by providing nutritional counseling, helping patients to manage and track their disease symptoms, and communicating with their providers. After the initial design has been tested by a group of NEALS patients and their caregivers, the study will advertise the app widely to recruit a larger group of ALS patients to measure nutrition and outcomes.

Study Sponsor:

Massachusetts General Hospital

Participant Duration:

Estimated Enrollment:

200

Estimated Study Start Date:

08/31/2019

Estimated Study Completion Date:

12/31/2021

Posting Last Modified Date:

08/12/2019

Date Study Added to alsconsortium.org:

08/12/2019
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    1. Participants with a diagnosis of ALS (self-reported)
    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 access to an iOS or Android device to allow the to download the apps.

    Exclusion criteria:

    1. Use of a feeding tube (G-tube or J-tube)
    2. BMI>30 kg/m2 regardless of weight loss history
    3. A history of cardiovascular disease (stroke, myocardial infarction, peripheral vascular disease)
    4. A history of diabetes (self-reported)

  • Site Contact Information

    Massachusetts General Hospital
    Mansi Sharma / .(JavaScript must be enabled to view this email address) / 617-643-2400
    Boston, Massachusetts
    United States