Diet, HealthyPLANTNCT05678075
The Stanford Plant-based Educational Study: Providers Learning About Nutrition Together (PLANT)
A study testing Whole-food plant-based nutrition education in people with Diet, Healthy, run by Stanford University at 1 site in United States.
Trial summary
More than 70% of chronic illnesses can be prevented or reversed with a whole-food, plant-based diet (WFPBD). This dietary pattern is also more sustainable for our planetary health. The majority of physicians receive fewer than 20 hours of nutrition education during the entire course of their medical training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Whole-food plant-based nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 10 Aug 2023
- 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
- Clinical personnel at Stanford who agree to participate in this nutritional intervention study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Educational Campaign to Stimulate Adoption of a Whole-Food Plant-Based Diet Amongst Stanford Physicians: The PLANT Study (Providers Learning About Nutrition Together)
More than 70% of chronic illnesses can be prevented or reversed with a whole-food, plant-based diet (WFPBD). This dietary pattern is also more sustainable for our planetary health. The majority of physicians receive fewer than 20 hours of nutrition education during the entire course of their medical training. Although many physicians are aware of the importance of diet on their well-being, they face significant barriers in following a healthy diet. Because physicians' own habits strongly influence patient health habits, the investigators theorize that physicians who eat a WFPBD themselves will be much more likely to successfully counsel their patients on nutrition and recommend a WFPBD.
The most effective methods that can be successfully used to encourage busy physicians to adopt a WFPBD have not yet been identified. Given the increasing rates of diet-related chronic illnesses, if proven effective, this study may offer a new scalable approach to encourage physicians, and ultimately their patients, to adopt a WFPBD.
Read more
The aims of this study are to:
- Assess the impact of a multimodal 6-week educational program on WFPBD on a) change in physicians' diet type and quality, b) change in mindset about WFPBD, and c) stage of change based on the transtheoretical model of behavior change (Figure 1), compared to the delayed-intervention (control group) from baseline to week 6.
- Assess the impact of the 6-week educational program on the development of skills and knowledge required to a) adopt a WFPBD and b) counsel patients on the same.
Read the detailed description
Study overview:
This is a randomized, delayed intervention trial testing a flexible, multimodal WFPBD educational program for 6 weeks for providers at Stanford in any department.
Research Activities:
- Screening: Interested participants will participate in a Qualtrics survey, which will determine eligibility.
- Enrollment: If the provider expresses interest in participating, the research team will send an email that explains details about the study. A waiver of consent will be utilized given minimal risk.
- Intervention: a 6-week multimodal educational intervention program. We will utilize a pre- and post-study survey which will include information on current dietary habits and use of Diet ID (assessment of diet type and quality). We will also assess their mindset for adopting a WFPBD. Finally, we will assess measures of motivation and confidence to adopt a WFPBD and to prescribe a WFPBD to patients. The educational program will include interactive didactic sessions, cooking classes, and weekly emails with suggested resources and activities including movies, recipes, and websites.
- Conditions
- Diet, Healthy
- Being tested
- Whole-food plant-based nutrition education
- Keywords
- plant-based diet, physician nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-food plant-based nutrition educationBehavioural
Participants will receive an educational intervention regarding the benefits of a whole food plant-based diet and how to incorporate more plant-based foods into their diets. The intervention will last 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whole food plant-based nutrition education | Active comparator | Providers will receive an educational intervention on whole food plant based nutrition that will last 6 weeks. Receives: Behavioral: Whole-food plant-based nutrition education |
| Delayed intervention | No intervention | Providers will receive a educational intervention on whole food plant based nutrition that will last 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diet ID score from baseline to Week 6
Change in Diet ID score (measuring diet type and quality, on an ordinal scale of 1-10 with higher values representing better quality) will be assessed using the validated Diet ID tool
Measured: 6 weeks
Change in mindset about WFPBD from baseline to week 6
Change in mindset about WFPBD will be assessed using a validated survey
Measured: 6 weeks
Change in state of change (motivation/confidence) from baseline to week 6
Change in stage of change (motivation and confidence) will be assessed using the validated survey for transtheoretical model of behavior change
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start25 May 2023
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamiko Katsumoto, Stanford University
- Investigators
- Tamiko Katsumoto, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678075
- Sponsor's protocol ID
- 68145
- Acronym
- PLANT
- Status last verified
- Feb 2024
- First submitted
- 1 Jan 2023
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Campaign to Stimulate Adoption of a Whole-Food Plant-Based Diet Amongst Stanford Physicians: The PLANT Study (Providers Learning About Nutrition Together)
- ClinicalTrials.gov ID
- NCT05678075
- Acronym / sponsor ID
- PLANT / 68145
- Conditions
- Diet, Healthy
- Keywords
- plant-based diet, physician nutrition education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 10 Jan 2023 (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.
More than 70% of chronic illnesses can be prevented or reversed with a whole-food, plant-based diet (WFPBD). This dietary pattern is also more sustainable for our planetary health. The majority of physicians receive fewer than 20 hours of nutrition education during the entire course of their medical training. Although many physicians are aware of the importance of diet on their well-being, they face significant barriers in following a healthy diet. Because physicians' own habits strongly influence patient health habits, the investigators theorize that physicians who eat a WFPBD themselves will be much more likely to successfully counsel their patients on nutrition and recommend a WFPBD.
The most effective methods that can be successfully used to encourage busy physicians to adopt a WFPBD have not yet been identified. Given the increasing rates of diet-related chronic illnesses, if proven effective, this study may offer a new scalable approach to encourage physicians, and ultimately their patients, to adopt a WFPBD.
The aims of this study are to:
- Assess the impact of a multimodal 6-week educational program on WFPBD on a) change in physicians' diet type and quality, b) change in mindset about WFPBD, and c) stage of change based on the transtheoretical model of behavior change (Figure 1), compared to the delayed-intervention (control group) from baseline to week 6.
- Assess the impact of the 6-week educational program on the development of skills and knowledge required to a) adopt a WFPBD and b) counsel patients on the same.
Detailed description
Study overview:
This is a randomized, delayed intervention trial testing a flexible, multimodal WFPBD educational program for 6 weeks for providers at Stanford in any department.
Research Activities:
- Screening: Interested participants will participate in a Qualtrics survey, which will determine eligibility.
- Enrollment: If the provider expresses interest in participating, the research team will send an email that explains details about the study. A waiver of consent will be utilized given minimal risk.
- Intervention: a 6-week multimodal educational intervention program. We will utilize a pre- and post-study survey which will include information on current dietary habits and use of Diet ID (assessment of diet type and quality). We will also assess their mindset for adopting a WFPBD. Finally, we will assess measures of motivation and confidence to adopt a WFPBD and to prescribe a WFPBD to patients. The educational program will include interactive didactic sessions, cooking classes, and weekly emails with suggested resources and activities including movies, recipes, and websites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole food plant-based nutrition education | Active comparator | Behavioral: Whole-food plant-based nutrition educationProviders will receive an educational intervention on whole food plant based nutrition that will last 6 weeks. |
| Delayed intervention | No intervention | –Providers will receive a educational intervention on whole food plant based nutrition that will last 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical personnel at Stanford who agree to participate in this nutritional intervention study
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 |
|---|---|---|
| Whole-food plant-based nutrition educationParticipants will receive an educational intervention regarding the benefits of a whole food plant-based diet and how to incorporate more plant-based foods into their diets. The intervention will last 6 weeks. | Behavioural | Whole food plant-based nutrition education |
Primary outcome
Change in Diet ID score from baseline to Week 6
Time frame: 6 weeks
Change in Diet ID score (measuring diet type and quality, on an ordinal scale of 1-10 with higher values representing better quality) will be assessed using the validated Diet ID tool
Change in mindset about WFPBD from baseline to week 6
Time frame: 6 weeks
Change in mindset about WFPBD will be assessed using a validated survey
Change in state of change (motivation/confidence) from baseline to week 6
Time frame: 6 weeks
Change in stage of change (motivation and confidence) will be assessed using the validated survey for transtheoretical model of behavior change
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Tamiko Katsumoto, MD principal investigator
Stanford 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 Whole-food plant-based nutrition education in people with Diet, Healthy, run by Stanford 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 1 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 13 Feb 2024. 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?
Change in Diet ID score from baseline to Week 6 (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 13 Feb 2024.