Nutrition DisordersNCT04196517
PALS for Nutrition Education
A study testing Educational Tool, PALS and WebMD in people with Nutrition Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Educational Tool, PALS and WebMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nutrition Disorders
- Being tested
- Educational Tool, PALS, WebMD
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Tool, PALSOther
The Patient Activated Learning System is a free, health education platform.
WebMDOther
WebMD is a widely used educational platform for health information.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - PALS | Experimental | The Patient Activated Learning System (Palsforhealth.com) Receives: Other: Educational Tool, PALS |
| Arm 2 - WebMD | Experimental | WebMD.com Receives: Other: WebMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, as measured by assessment questions on the nutrition information provided
Measured: Day 1, Immediately after reading article
Secondary outcomes (1)
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.
Measured: Day 1, Immediately after reading article
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start12 Feb 2020
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Why it stopped: COVID-19 paused study temporarily due to no clinical encounters
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Safford, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196517
- Sponsor's protocol ID
- 19-11021133
- Status last verified
- Mar 2021
- First submitted
- 10 Dec 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Patient Activated Learning System (PALS) Serve as a Better Model for Nutrition Education Than Other Online-based Educational Material?
- ClinicalTrials.gov ID
- NCT04196517
- Acronym / sponsor ID
- 19-11021133
- Conditions
- Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 paused study temporarily due to no clinical encounters
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - PALS | Experimental | Other: Educational Tool, PALSThe Patient Activated Learning System (Palsforhealth.com) |
| Arm 2 - WebMD | Experimental | Other: WebMDWebMD.com |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Tool, PALSThe Patient Activated Learning System is a free, health education platform. | Other | Arm 1 - PALS |
| WebMDWebMD is a widely used educational platform for health information. | Other | Arm 2 - WebMD |
Primary outcome
Knowledge, as measured by assessment questions on the nutrition information provided
Time frame: Day 1, Immediately after reading article
1 secondary outcome
E-health usability, as measured by questions from the Kelly et al. scale
Time frame: Day 1, Immediately after reading article
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Nutrition Disorders
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Safford, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Tool, PALS and WebMD in people with Nutrition Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, as measured by assessment questions on the nutrition information provided (time frame: Day 1, Immediately after reading article). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.