Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02418546
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	April 2015
Completion date	March 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02915848` - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting	`NCT03648905` - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated	`NCT02688465` - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).	Phase 4
Completed	`NCT05040048` - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting	`NCT04006210` - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations	Phase 3
Completed	`NCT02562768` - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease	Phase 1
Completed	`NCT00105521` - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia	Phase 3
Completed	`NCT00105508` - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia	Phase 3
Recruiting	`NCT06002581` - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease	N/A
Completed	`NCT02236260` - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation	N/A
Completed	`NCT00529724` - Body Weight Gain, Parkinson, Subthalamic Stimulation	Phase 2
Active, not recruiting	`NCT05699460` - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed	`NCT03703570` - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations	Phase 2
Completed	`NCT03462680` - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures	N/A
Completed	`NCT02837172` - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting	`NCT04046276` - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease	N/A
Recruiting	`NCT02952391` - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol	N/A
Active, not recruiting	`NCT02937324` - The CloudUPDRS Smartphone Software in Parkinson's Study.	N/A
Completed	`NCT02874274` - Vaccination Uptake (VAX) in PD	N/A
Terminated	`NCT02894567` - Evaluation of Directional Recording and Stimulation Using spiderSTN	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms