N/A
N=78
Electronic-health Application To Measure Outcomes REmotely Clinical Trial
Neurodegenerative Disease · Weight Loss · Amyotrophic Lateral Sclerosis · Parkinson's Disease · Huntington's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02418546 ↗Enrolled (actual)
78
Serious AEs
14.1%
Results posted
Apr 2020
Primary outcome: Primary: Estimated Mean Change in Weight From Baseline to 6 Months — -0.1; -0.2; -1.2 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In-Person Nutritional Counseling by a Registered Dietitian (Behavioral); Nutritional counseling using an e-Health Application (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Mean Change in Weight From Baseline to 6 Months |
-0.1; -0.2; -1.2 | — |
| SECONDARY Change in Calorie Intake Over Time |
— | — |
| SECONDARY Safety: Frequency of Adverse Events |
— | — |
| SECONDARY Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
- Male or female subjects aged 18 years or older.
- Participants must be capable of providing informed consent and complying with trial procedures.
- Participants must have an MGH swallowing screening tool score>5 at the time of the screening visit
- Participants or a designated caregiver must be able to obtain home weights and communicate to their RD
Exclusion Criteria
- Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
- BMI > 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.
Data sourced from ClinicalTrials.gov (NCT02418546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.