Status:
COMPLETED
The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04051333
Start Date
March 30 2020
End Date
December 31 2021
Last Update
February 8 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114