Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Study Overview
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Brief Summary
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This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.

Detailed Description
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This is a single center, randomized, open-label, placebo controlled, parallel group study. The study treatment period is approximately 6 months and observation period is approximately 7 months. There are three parallel treatment groups: in-person nutritional counseling, nutritional counseling using an e-Health App, and standard care. Subjects will be randomly assigned in a 1:1:1 ratio using a computer-generated randomization scheme. Subjects in the two intervention arms will be given caloric recommendations designed to cause weight stability or modest weight gain, depending on their current BMI and weight loss history. All participants in the intervention arms will receive counseling either in-person or remotely through the App by registered dietitians (RD) working in the Bionutrition department of the Clinical Research Center at MGH. At MGH, approximately 150 ALS subjects (50 per treatment group) will be enrolled. Approximately 75-150 PD and HD subjects will enroll.

Official Title
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Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Conditions
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Neurodegenerative Disease, Weight Loss, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Huntington's Disease, Cachexia

Intervention / Treatment
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* Behavioral: In-Person Nutritional Counseling by a Registered Dietitian
* Behavioral: Nutritional counseling using an e-Health Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person Nutritional Counseling<br>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. | Behavioral: In-Person Nutritional Counseling by a Registered Dietitian<br> <br> |
| Experimental: E-Health App for Nutritional Counseling<br>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. | Behavioral: Nutritional counseling using an e-Health Application<br> <br> |
| No Intervention: Standard Care<br>Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Mean Change in Weight 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 over time from Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Calorie Intake Over Time | 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 | Change from baseline over 6 months | 
| Safety: Frequency of Adverse Events | To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. | From baseline to month 7 (one month after 6 month end of study visit) | 
| Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions |  | Baseline, 3 months and 6 months |