Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)
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ClinicalTrials.gov Identifier: NCT02418546 |
Recruitment Status :
Completed
First Posted : April 16, 2015
Results First Posted : April 20, 2020
Last Update Posted : April 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neurodegenerative Disease Weight Loss Amyotrophic Lateral Sclerosis Parkinson's Disease Huntington's Disease Cachexia | Behavioral: In-Person Nutritional Counseling by a Registered Dietitian Behavioral: Nutritional counseling using an e-Health Application | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Electronic-health Application To Measure Outcomes REmotely Clinical Trial |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
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Active Comparator: In-Person Nutritional Counseling
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
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Behavioral: In-Person Nutritional Counseling by a Registered Dietitian |
Experimental: E-Health App for Nutritional Counseling
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
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Behavioral: Nutritional counseling using an e-Health Application |
No Intervention: Standard Care
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
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- Estimated Mean Change in Weight From Baseline to 6 Months [ Time Frame: Change over time from Baseline to 6 months ]The Primary Aim is to study the feasibility and efficacy to maintain or increase body weight of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. Weights were measured in the clinic every 3 months.
- Change in Calorie Intake Over Time [ Time Frame: Change from baseline over 6 months ]Secondary aims include measuring the number of calories required to maintain or increase body weight in patients with neurodegenerative diseases. Total daily energy intake was calculated using 4 day food records at baseline, 3 months and 6 months
- Safety: Frequency of Adverse Events [ Time Frame: From baseline to month 7 (one month after 6 month end of study visit) ]To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.
- Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions [ Time Frame: Baseline, 3 months and 6 months ]
- Exploratory Efficacy Measure: Survival [ Time Frame: baseline to 18 months ]Vital status will be measured until the last subject last visit.
- Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: Change over time from Baseline to 6 months ]Disease progression will be measured using disease-specific outcome measures (the ALSFRS-R scale). The range of the ALSFRS-R is 0-40 with higher scores indicating better function. Change in ALSFRS-R is reported as units/month.
- Exploratory Efficacy Measure: Quality of Life [ Time Frame: 18 months ]Quality of life will be measured using the PROMIS SF 1.1 in units.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
- 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 an MGH swallowing screening tool score>5 at the time of the screening visit
- Participants or a designated caregiver must be able to obtain home weights and communicate to their RD
Exclusion Criteria:
- Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
- BMI > 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418546
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Anne-Marie Wills, MD | Massachusetts General Hospital |
Documents provided by Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital:
Responsible Party: | Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT02418546 |
Other Study ID Numbers: |
2015P000258 |
First Posted: | April 16, 2015 Key Record Dates |
Results First Posted: | April 20, 2020 |
Last Update Posted: | April 20, 2020 |
Last Verified: | April 2020 |
Parkinson Disease Motor Neuron Disease Amyotrophic Lateral Sclerosis Huntington Disease Neurodegenerative Diseases Weight Loss Cachexia Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Body Weight Changes |
Body Weight Neuromuscular Diseases Spinal Cord Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Dementia Chorea Dyskinesias Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Emaciation |