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

Mass General Brigham

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: ALS Nutrition App (MyDataHelps platform)

Study type: Observational

Funder types: Other

Identifiers

NCT04051333

2019P001649

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)