Skip to main content
OpenTrials
Completed

NCT Number: NCT04051333

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with a diagnosis of ALS (self-reported)
  • Male or female subjects aged 18 years or older.
  • Participants must be capable of providing informed consent and complying with trial procedures.
  • Participants must have access to an iOS or Android device to allow the to download the apps.

Exclusion criteria

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

Treatment and study plan

ALS Nutrition App (MyDataHelps platform)

Device

We have designed a mobile health app to provide nutritional counseling and to measure disease outcomes both through self-reported questionnaires and through passive data collection.

Primary outcomes

  1. Patient Reported Outcome Measurement Information System Short Form v1.0

    Time frame: Change over time over 6 months

    Patient Reported Global Health Questionnaire where the higher the T score the better

Secondary outcomes

  1. ALS Functional Rating Scale-Revised

    Time frame: Change over time over 6 months

    The ALSFRS-R total score ranges from 0-40 with higher scores better

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • ALS Association

Registry information

Acronym: EAT MORE2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2019
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.