The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)
EAT MORE2
1 other identifier
observational
87
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 8, 2022
February 1, 2022
1.8 years
August 6, 2019
February 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Reported Outcome Measurement Information System Short Form v1.0
Patient Reported Global Health Questionnaire where the higher the T score the better
Change over time over 6 months
Secondary Outcomes (1)
ALS Functional Rating Scale-Revised
Change over time over 6 months
Interventions
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.
Eligibility Criteria
Adults with ALS without dysphagia, diabetes or cardiovascular disease
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- ALS Associationcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Wills AM, Garry J, Hubbard J, Mezoian T, Breen CT, Ortiz-Miller C, Nalipinski P, Sullivan S, Berry JD, Cudkowicz M, Paganoni S, Chan J, Macklin EA. Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS. BMC Neurol. 2019 May 29;19(1):104. doi: 10.1186/s12883-019-1330-6.
PMID: 31142272BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 9, 2019
Study Start
March 30, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
February 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share