Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)

• ClinicalTrials.gov Identifier: NCT02418546
• Recruitment Status: Completed
• First Posted: April 16, 2015
• Results First Posted: April 20, 2020
• Last Update Posted: April 20, 2020
• Sponsor: Massachusetts General Hospital
• Collaborator: ALS Association
• Information provided by (Responsible Party): Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

ALS Association

Investigators

• Principal Investigator: Anne-Marie Wills, MD; Massachusetts General Hospital

  Study Documents (Full-Text)

Documents provided by Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital:

Study Protocol  [PDF] March 10, 2016

Statistical Analysis Plan  [PDF] April 11, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wills AM, Garry J, Hubbard J, Mezoian T, Breen CT, Ortiz-Miller C, Nalipinski P, Sullivan S, Berry JD, Cudkowicz M, Paganoni S, Chan J, Macklin EA. Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS. BMC Neurol. 2019 May 29;19(1):104. doi: 10.1186/s12883-019-1330-6.

• 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
• Results First Posted: April 20, 2020
• Last Update Posted: April 20, 2020
• Last Verified: April 2020

Additional relevant MeSH terms:

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; 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