Electronic-health Application To Measure Outcomes REmotely Clinical Trial (EAT MORE)
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|ClinicalTrials.gov Identifier: NCT02418546|
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : April 20, 2020
Last Update Posted : April 20, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|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|
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.
- 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.
- 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
- 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.
- 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 ]
- Exploratory Efficacy Measure: Survival [ Time Frame: baseline to 18 months ]Vital status will be measured until the last subject last visit.
- 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.
- Exploratory Efficacy Measure: Quality of Life [ Time Frame: 18 months ]Quality of life will be measured using the PROMIS SF 1.1 in units.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418546
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Anne-Marie Wills, MD||Massachusetts General Hospital|