Study Purpose:
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.Study Status:
Not recruiting
Disease:
Neurodegenerative Disease , Weight Loss , Amyotrophic Lateral Sclerosis , Parkinson's Disease , Huntington's Disease , Cachexia
Study Type:
Interventional
Type of Intervention:
Behavioral
Intervention Name:
In-Person Nutritional Counseling by a Registered Dietitian, Nutritional counseling using an e-Health Application
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Anne-Marie Wills, MD, Massachusetts General Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Mass General Hospital
Boston, Massachusetts, 02114 United States
Full Study Summary:
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 Sponsor:
Massachusetts General Hospital
Participant Duration:
The study treatment period is approximately 6 months and observation period is approximately 7 months.
Estimated Enrollment:
78
Estimated Study Start Date:
03 / 31 / 2015
Estimated Study Completion Date:
03 / 01 / 2018
Posting Last Modified Date:
04 / 20 / 2020
Date Study Added to neals.org:
04 / 16 / 2015
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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.
Massachusetts General Hospital
Boston, Massachusetts
02114
United States