- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196517
PALS for Nutrition Education
March 16, 2021 updated by: Weill Medical College of Cornell University
Can the Patient Activated Learning System (PALS) Serve as a Better Model for Nutrition Education Than Other Online-based Educational Material?
The overall goal of this inquiry is to determine whether PALS is more effective than comparable online resources at educating patients in the outpatient clinic setting about nutrition.
Participants will be randomly assigned to view either a PALS article or WebMD article on the same nutrition topic.
Participants will then fill out a post-survey to assess knowledge uptake and attitudes regarding healthy eating.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient ≥ 18 years of age.
- Ability to speak and read in English.
- Passing the screener - Mini-Mental Status Examination.
- Patient at WCIMA clinic on Upper East Side of Manhattan, NY.
Exclusion Criteria:
- Non-English speakers
- Inability to read in English
- Being younger than 18
- Not passing the screener
- Not a patient at WCIMA clinic on Upper East Side of Manhattan, NY.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1 - PALS
The Patient Activated Learning System (Palsforhealth.com)
|
The Patient Activated Learning System is a free, health education platform.
|
Experimental: Arm 2 - WebMD
WebMD.com
|
WebMD is a widely used educational platform for health information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge, as measured by assessment questions on the nutrition information provided
Time Frame: Day 1, Immediately after reading article
|
Day 1, Immediately after reading article
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
E-health usability, as measured by questions from the Kelly et al. scale
Time Frame: Day 1, Immediately after reading article
|
Questions to understand the user's understanding, preference and trust of the information based on a 5-point likert scale with 5 being strongly agree in favor.
|
Day 1, Immediately after reading article
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Monika Safford, MD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2020
Primary Completion (Actual)
March 16, 2021
Study Completion (Actual)
March 16, 2021
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (Actual)
December 12, 2019
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-11021133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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