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NCT Number: NCT02418546

Electronic-health Application To Measure Outcomes REmotely Clinical Trial

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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Key information

Conditions

Neurodegenerative Disease Amyotrophic Lateral Sclerosis Basal Ganglia Diseases Body Weight Body Weight Changes Brain Diseases Cachexia Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Huntington's Disease Mental Disorders Metabolic Diseases Motor Neuron Disease Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Spinal Cord Diseases Synucleinopathies TDP-43 Proteinopathies Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-Person Nutritional Counseling by a Registered Dietitian

Behavioral

Nutritional counseling using an e-Health Application

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Other outcomes

  1. Exploratory Efficacy Measure: Survival

    Time frame: baseline to 18 months

    Vital status will be measured until the last subject last visit.

  2. 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.

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • ALS Association

Registry information

Acronym: EAT MORE

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 16, 2015
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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