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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02418546
Other study ID # 2015P000258
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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