PALS for Nutrition Education
Primary Purpose
Nutrition Disorders
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Tool, PALS
WebMD
Sponsored by
About this trial
This is an interventional health services research trial for Nutrition Disorders
Eligibility Criteria
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.
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1 - PALS
Arm 2 - WebMD
Arm Description
The Patient Activated Learning System (Palsforhealth.com)
WebMD.com
Outcomes
Primary Outcome Measures
Knowledge, as measured by assessment questions on the nutrition information provided
Secondary Outcome Measures
E-health usability, as measured by questions from the Kelly et al. scale
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.
Full Information
NCT ID
NCT04196517
First Posted
December 10, 2019
Last Updated
March 16, 2021
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04196517
Brief Title
PALS for Nutrition Education
Official Title
Can the Patient Activated Learning System (PALS) Serve as a Better Model for Nutrition Education Than Other Online-based Educational Material?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 paused study temporarily due to no clinical encounters
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - PALS
Arm Type
Experimental
Arm Description
The Patient Activated Learning System (Palsforhealth.com)
Arm Title
Arm 2 - WebMD
Arm Type
Experimental
Arm Description
WebMD.com
Intervention Type
Other
Intervention Name(s)
Educational Tool, PALS
Intervention Description
The Patient Activated Learning System is a free, health education platform.
Intervention Type
Other
Intervention Name(s)
WebMD
Intervention Description
WebMD is a widely used educational platform for health information.
Primary Outcome Measure Information:
Title
Knowledge, as measured by assessment questions on the nutrition information provided
Time Frame
Day 1, Immediately after reading article
Secondary Outcome Measure Information:
Title
E-health usability, as measured by questions from the Kelly et al. scale
Description
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.
Time Frame
Day 1, Immediately after reading article
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Safford, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PALS for Nutrition Education
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