Medical EducationNCT03044717
Nutrition Education in Fellows
An observational study of Medical Education, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to assess comfort of cardiology fellows and faculty with nutrition and its role in cardiovascular disease and to determine if increasing education in this arena will change clinical practice. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- Nutrition survey, Educational Conference and 3-hour nutrition module
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 27 Jan 2018
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiology fellow, faculty, internal medicine, residents, fellows
Who may be able to join
- All general cardiology fellow, faculty, internal medicine, residents, fellows will be asked to be part of this study.
- Male or females, 25 years or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: How Nutrition Education in Cardiology Fellows and Faculty Affects Clinical Practice Over a Six-Month Period
The purpose of this research study is to assess comfort of cardiology fellows and faculty with nutrition and its role in cardiovascular disease and to determine if increasing education in this arena will change clinical practice.
Read the detailed description
The aim of this project is to educate the fellows and faculty about nutrition. This will be done with a 3-hour nutrition module provided by the Gaples Institute. The Gaples Institute is a non-profit organization advocating natural strategies balanced with conventional medicine. The module will be provided free of charge for this education. There will also be a prevention education conference once every five weeks.
The secondary aim is to affect change in clinical practice among fellows and faculty. With an intensive nutrition education spanned over six months, the goal is to see if investigators can affect change in clinical practice. The nutrition module online will be available to those who participate in the study. The study participants are required to complete the 3-hour nutrition module prior to the six month completion of this study.
- Conditions
- Medical Education
- Being tested
- Nutrition survey, Educational Conference, 3-hour nutrition module
- Keywords
- Nutrition Education, Cardiology Fellows
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition surveyOther
Survey will be done prior to the initiation of the education
Educational ConferenceOther
A prevention educational conference will be available to attend once every 5 weeks.
3-hour nutrition moduleOther
Also called Nutrition module
Nutrition module will be provided by the Gaples Institute to participants as part of this study. This will be completed online via e-mail
| Study group | Role | What they receive |
|---|---|---|
| Cardiology fellows and faculty | Fill out a nutrition survey three times at 0, 3, and 6 months and be present at a prevention educational conference every 5 weeks until the end of the study.
This group will also complete a 3-hour nutrition module prior to study completion. Receives: Other: Nutrition survey; Other: Educational Conference; Other: 3-hour nutrition module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in behavior will be measured by method of Nutrition Survey
Nutrition Survey will be assessed at baseline, 3 months, and 6 months for changes in behavior.
Measured: Change from Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start2 Feb 2017
- Primary completion21 Jul 2017
- Study completion27 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Aggarwal, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044717
- Sponsor's protocol ID
- IRB201700026
- Status last verified
- Jan 2018
- First submitted
- 2 Feb 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Survey data will be maintained on an electronic enrollment log created and maintained by research staff. The electronic enrollment log will be maintained on a secure institutional server and only accessible to research staff. When the project is closed, the enrollment log with identifiable information will be destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Nutrition Education in Cardiology Fellows and Faculty Affects Clinical Practice Over a Six-Month Period
- ClinicalTrials.gov ID
- NCT03044717
- Acronym / sponsor ID
- IRB201700026
- Conditions
- Medical Education
- Keywords
- Nutrition Education, Cardiology Fellows
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 27 Jan 2018 (actual)
- First posted
- 7 Feb 2017 (estimated)
- 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 purpose of this research study is to assess comfort of cardiology fellows and faculty with nutrition and its role in cardiovascular disease and to determine if increasing education in this arena will change clinical practice.
Detailed description
The aim of this project is to educate the fellows and faculty about nutrition. This will be done with a 3-hour nutrition module provided by the Gaples Institute. The Gaples Institute is a non-profit organization advocating natural strategies balanced with conventional medicine. The module will be provided free of charge for this education. There will also be a prevention education conference once every five weeks.
The secondary aim is to affect change in clinical practice among fellows and faculty. With an intensive nutrition education spanned over six months, the goal is to see if investigators can affect change in clinical practice. The nutrition module online will be available to those who participate in the study. The study participants are required to complete the 3-hour nutrition module prior to the six month completion of this study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiology fellows and faculty | – | Other: Nutrition survey, Other: Educational Conference, Other: 3-hour nutrition moduleFill out a nutrition survey three times at 0, 3, and 6 months and be present at a prevention educational conference every 5 weeks until the end of the study. This group will also complete a 3-hour nutrition module prior to study completion. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology fellow, faculty, internal medicine, residents, fellows
Key inclusion criteria (2 listed)
- All general cardiology fellow, faculty, internal medicine, residents, fellows will be asked to be part of this study.
- Male or females, 25 years or older
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nutrition surveySurvey will be done prior to the initiation of the education | Other | Cardiology fellows and faculty |
| Educational ConferenceA prevention educational conference will be available to attend once every 5 weeks. | Other | Cardiology fellows and faculty |
| 3-hour nutrition moduleAlso: Nutrition moduleNutrition module will be provided by the Gaples Institute to participants as part of this study. This will be completed online via e-mail | Other | Cardiology fellows and faculty |
Primary outcome
Changes in behavior will be measured by method of Nutrition Survey
Time frame: Change from Baseline, 3 months, and 6 months
Nutrition Survey will be assessed at baseline, 3 months, and 6 months for changes in behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No. Survey data will be maintained on an electronic enrollment log created and maintained by research staff. The electronic enrollment log will be maintained on a secure institutional server and only accessible to research staff. When the project is closed, the enrollment log with identifiable information will be destroyed.
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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.
Monica Aggarwal, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Education, run by University of Florida 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in behavior will be measured by method of Nutrition Survey (time frame: Change from Baseline, 3 months, and 6 months). 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 1 Feb 2018.