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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02418546
• Collaborator: ALS Association (Other)
• Enrollment: 78
• Location: 1
• Arms: 3
• Duration (Months): 35
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

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	N/A

Detailed 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

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• 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: Apr 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Estimated Mean Change in Weight From Baseline to 6 Months [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.

Secondary Outcome Measures

1. Change in Calorie Intake Over Time [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

2. Safety: Frequency of Adverse Events [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.

3. 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]

Other Outcome Measures

1. Exploratory Efficacy Measure: Survival [baseline to 18 months]

   Vital status will be measured until the last subject last visit.

2. Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R) [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.

3. Exploratory Efficacy Measure: Quality of Life [18 months]

   Quality of life will be measured using the PROMIS SF 1.1 in units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• ALS Association

Investigators

• Principal Investigator: Anne-Marie Wills, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol - Mar 10, 2016
• Statistical Analysis Plan - Apr 11, 2018

More Information

Publications

None provided.

• Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02418546
• Other Study ID Numbers: 2015P000258
• First Posted: Apr 16, 2015
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Parkinson Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Huntington Disease; Neurodegenerative Diseases; Weight Loss; Cachexia

Study Results

Participant Flow

Arm/Group Title	In-Person Nutritional Counseling	E-Health App for Nutritional Counseling	Standard Care
Arm/Group Description	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. In-Person Nutritional Counseling by a Registered Dietitian	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. Nutritional counseling using an e-Health Application	Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
Period Title: Overall Study
STARTED	26	26	26
COMPLETED	19	20	23
NOT COMPLETED	7	6	3

Baseline Characteristics

Arm/Group Title	In-Person Nutritional Counseling	E-Health App for Nutritional Counseling	Standard Care	Total
Arm/Group Description	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. In-Person Nutritional Counseling by a Registered Dietitian	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. Nutritional counseling using an e-Health Application	Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.	Total of all reporting groups
Overall Participants	26	26	26	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (11.9)	54.7 (11.5)	57.5 (10.9)	56.9 (11.5)
Sex: Female, Male (Count of Participants)
Female	10 38.5%	6 23.1%	15 57.7%	31 39.7%
Male	16 61.5%	20 76.9%	11 42.3%	47 60.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.8%	1 3.8%	2 7.7%	4 5.1%
Not Hispanic or Latino	25 96.2%	25 96.2%	24 92.3%	74 94.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	26 100%	26 100%	26 100%	78 100%
ALS Functional Rating Scale-Revised (Total score in points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Total score in points]	34.9 (6.67)	37.4 (6.19)	36.7 (5.36)	36.4 (6.21)

Outcome Measures

1. Primary Outcome

Title	Estimated Mean Change in Weight From Baseline to 6 Months
Description	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.
Time Frame	Change over time from Baseline to 6 months

Outcome Measure Data

Analysis Population Description

Please note that these are Parameter Estimates rather than "means"

Arm/Group Title	In-Person Nutritional Counseling	E-Health App for Nutritional Counseling	Standard Care
Arm/Group Description	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. In-Person Nutritional Counseling by a Registered Dietitian	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. Nutritional counseling using an e-Health Application	Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
Measure Participants	26	26	26
Mean (95% Confidence Interval) [kg]	-0.1	-0.2	-1.2

2. Secondary Outcome

Title	Change in Calorie Intake Over Time
Description	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
Time Frame	Change from baseline over 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Safety: Frequency of Adverse Events
Description	To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.
Time Frame	From baseline to month 7 (one month after 6 month end of study visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Exploratory Efficacy Measure: Survival
Description	Vital status will be measured until the last subject last visit.
Time Frame	baseline to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R)
Description	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.
Time Frame	Change over time from Baseline to 6 months

Outcome Measure Data

Analysis Population Description

Change over time of continuous, longitudinal measures was analyzed using a shared-baseline, mixed effect model with fixed effects for visit and an interaction between post-baseline visit and study arm and with a random slope and intercept for each subject with unstructured covariance.

Arm/Group Title	In-Person Nutritional Counseling	E-Health App for Nutritional Counseling	Standard Care
Arm/Group Description	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. In-Person Nutritional Counseling by a Registered Dietitian	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. Nutritional counseling using an e-Health Application	Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
Measure Participants	26	26	26
Mean (95% Confidence Interval) [units per month]	-5.8	-2.6	-5.2

7. Other Pre-specified Outcome

Title	Exploratory Efficacy Measure: Quality of Life
Description	Quality of life will be measured using the PROMIS SF 1.1 in units.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	7 months
Arm/Group Title	In-Person Nutritional Counseling		E-Health App for Nutritional Counseling		Standard Care
Arm/Group Description	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. In-Person Nutritional Counseling by a Registered Dietitian		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. Nutritional counseling using an e-Health Application		Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
All Cause Mortality
	In-Person Nutritional Counseling		E-Health App for Nutritional Counseling		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.4%)		0/26 (0%)		1/26 (3.8%)
Serious Adverse Events
	In-Person Nutritional Counseling		E-Health App for Nutritional Counseling		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.4%)		5/26 (19.2%)		2/26 (7.7%)
Blood and lymphatic system disorders
Deep Venous Thrombosis	2/26 (7.7%)	2	0/26 (0%)	0	0/26 (0%)	0
Gastrointestinal disorders
Pancreatitis	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Gastroparesis	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Dysphagia	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Infections and infestations
Pneumonia	2/26 (7.7%)	2	0/26 (0%)	0	2/26 (7.7%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's Sarcoma	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Nervous system disorders
Lacunar Stroke	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Other (Not Including Serious) Adverse Events
	In-Person Nutritional Counseling		E-Health App for Nutritional Counseling		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/26 (34.6%)		11/26 (42.3%)		12/26 (46.2%)
Gastrointestinal disorders
sialorrhea	4/26 (15.4%)	4	0/26 (0%)	0	2/26 (7.7%)	2
Choking	1/26 (3.8%)	1	0/26 (0%)	0	2/26 (7.7%)	2
General disorders
Fatigue	0/26 (0%)	0	2/26 (7.7%)	2	1/26 (3.8%)	1
Injury, poisoning and procedural complications
Falls	7/26 (26.9%)	8	9/26 (34.6%)	13	9/26 (34.6%)	13
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/26 (0%)	0	1/26 (3.8%)	1	2/26 (7.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.