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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04051333
• Collaborator: ALS Association (Other)
• Enrollment: 87
• Location: 1
• Actual Duration (Months): 21.1
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Device: ALS Nutrition App (MyDataHelps platform)

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 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 Design

• Study Type: Observational
• Actual Enrollment: 87 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)
• Actual Study Start Date: Mar 30, 2020
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. Patient Reported Outcome Measurement Information System Short Form v1.0 [Change over time over 6 months]

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

Secondary Outcome Measures

1. ALS Functional Rating Scale-Revised [Change over time over 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• ALS Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04051333
• Other Study ID Numbers: 2019P001649
• First Posted: Aug 9, 2019
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Feb 8, 2022