Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-03-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

In-Person Nutritional Counseling by a Registered Dietitian

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Nutritional counseling using an e-Health Application

Intervention Type BEHAVIORAL

Standard Care

Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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In-Person Nutritional Counseling by a Registered Dietitian

Intervention Type BEHAVIORAL

Nutritional counseling using an e-Health Application

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
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 an MGH swallowing screening tool score\>5 at the time of the screening visit
5. Participants or a designated caregiver must be able to obtain home weights and communicate to their RD

Exclusion Criteria

1. Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
2. BMI \> 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No