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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
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 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
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.
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.
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.



Primary Outcome Measures :
  1. Weight: Measured in the clinic [ Time Frame: 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.


Secondary Outcome Measures :
  1. Calorie intake: Measured using 4 day food records [ Time Frame: 6 months ]
    Secondary aims include measuring the number of calories required to maintain or increase body weight in patients with neurodegenerative diseases.

  2. Safety: Frequency of adverse events [ Time Frame: 6 months ]
    To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.

  3. Tolerability: The number of participants who complete the study while complying with at least 80% of the counseling sessions [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Exploratory efficacy measure: Survival [ Time Frame: 18 months ]
    Vital status will be measured until the last subject last visit.

  2. Exploratory efficacy measure: Disease progression [ Time Frame: 6 months ]
    Disease progression will be measured using disease-specific outcome measures (ALSFRS-R in units/month, UDysRS in units, UHDRS in units/month).

  3. Exploratory efficacy measure: Quality of life [ Time Frame: 18 months ]
    Quality of life will be measured using the PROMIS SF 1.1 in units.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
ALS Association
Investigators
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Principal Investigator: Anne-Marie Wills, MD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Last Update Posted: March 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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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
Body Weight Changes
Body Weight
Signs and Symptoms
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