Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Parkinson's Disease Clinical Trial

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Official title:

Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418546
• Other study ID #: 2015P000258
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: April 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cachexia
• Huntington Disease
• Huntington's Disease
• Motor Neuron Disease
• Neurodegenerative Disease
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinson's Disease
• Weight Loss

Intervention

Behavioral:
• In-Person Nutritional Counseling by a Registered Dietitian

• Nutritional counseling using an e-Health Application

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Efficacy Measure: Survival	Vital status will be measured until the last subject last visit.	baseline to 18 months
Other	Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R)	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.	Change over time from Baseline to 6 months
Other	Exploratory Efficacy Measure: Quality of Life	Quality of life will be measured using the PROMIS SF 1.1 in units.	18 months
Primary	Estimated Mean Change in Weight 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.	Change over time from Baseline to 6 months
Secondary	Change in Calorie Intake Over Time	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	Change from baseline over 6 months
Secondary	Safety: Frequency of Adverse Events	To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.	From baseline to month 7 (one month after 6 month end of study visit)
Secondary	Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions		Baseline, 3 months and 6 months