Food NeophobiaNCT06090409
Encouraging a Plant Based Diet in an Underserved Urban Population
A study testing Implementing free/subsidized agricultural produce to encourage a plant-based diet. in people with Food Neophobia and Food Preferences, run by University of Louisville at 1 site in United States.
Trial summary
The investigator's goal is to promote a plant-based diet amongst the underserved urban population of Louisville with the help of educational aids and the provision of affordable resources. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Neophobia, Food Preferences, Dietary Habits
- What is being tested?
- Implementing free/subsidized agricultural produce to encourage a plant-based diet.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 31 Dec 2024
- 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
- Patients age 18 and older screening as food insecure since 2021
- Patients willing to complete survey data
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Anuja Abhyankar contact
United States1 site, 1 recruiting
- Recruiting
University of Louisville Ambulatory Internal Medicine Resident Clinic
Louisville, Kentucky, 40202
Erin Murphy, 502-592-2388, erin.murphy@louisville.edu
About this study
Official title: Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population
The investigator's goal is to promote a plant-based diet amongst the underserved urban population of Louisville with the help of educational aids and the provision of affordable resources.
Read the detailed description
Primary care clinic patients who screen positive for food insecurity between 2021-2023 will be eligible for this study (~200 patients). Patients will be recruited by one of four means: during standard clinic visits, or via phone, Electronic Medical Record message, or mail. Registry of patients will be de-identified and list of identifiers will be stored separately from the data set. Data will be stored on password protected computers only available to select research staff. Investigators will utilize a preamble in lieu of informed consent.
The primary outcome will be to measure the readiness of patients to adhere to a plant-based diet. Investigators will assess readiness using Food Neophobia inventory and will perform a brief Diet Inventory at simultaneous timepoints. Education surrounding benefits and easy ways to increase plant-based eating will be distributed to all participating patients. Enrollment in a local income-based subsidized Community Supported Agriculture share (weekly farm produce box during growing season) will be offered to all patients. Patients can opt into this service, and we will track which patients enroll. Before, during, and after the Community Sponsored Agriculture produce time period, Food Neophobia and Diet Inventory will be reassessed.
Adherence to plant-based eating between the patients who received access to subsidized food and education versus those who received education alone will be evaluated. Qualitative open-ended feedback will be obtained at all time points.
The secondary outcomes are to measure weight loss, reduction in blood pressure, and improvement in hemoglobin A1C and lipid profile wherever applicable.
Statistical significance is not attempting to be reached, but rather the associations between food neophobia and ability to change diet will be evaluated, as well as other qualitative open-ended feedback.
- Conditions
- Food Neophobia, Food Preferences, Dietary Habits
- Being tested
- Implementing free/subsidized agricultural produce to encourage a plant-based diet.
- Keywords
- Food Neophobia, Plant-based Diet
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementing free/subsidized agricultural produce to encourage a plant-based diet.Other
Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.
| Study group | Role | What they receive |
|---|---|---|
| Free/Subsidized Community Supported Agriculture (CSA) produce along with education. | Experimental | Patients who self-elect to enroll in subsidized/free Community-supported agriculture produce shares will also receive Education on the benefits of a plant-based diet. Receives: Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet. |
| Education Alone | Active comparator | Patients will receive educational information about the benefits of plant-based eating. Receives: Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Neophobia
Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Measured: 1 year
Diet Inventory
Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.
Measured: 1 year
Secondary outcomes (3)
Reduction in blood pressure
Systolic and diastolic blood pressure will be recorded when done per Standard of Care.
Measured: 1 year
Improvement in lipid profile
measure of hemoglobin A1C will be recorded when done per Standard of Care.
Measured: 1 year
Weight Loss
measure of weight will be recorded when done per Standard of Care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start14 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food NeophobiaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Oatly Group AB
- Responsible party
- Principal investigator, Erin Murphy, University of Louisville
- Investigators
- Erin Murphy, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090409
- Sponsor's protocol ID
- 23.0126
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient identifiers will be visible to Principal investigator and Co-Investigatory and kept in separate password-protected database. Other study investigators will see Individual Participant Data with identifiers removed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population
- ClinicalTrials.gov ID
- NCT06090409
- Acronym / sponsor ID
- 23.0126
- Conditions
- Food Neophobia, Food Preferences, Dietary Habits
- Keywords
- Food Neophobia, Plant-based Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Oatly Group AB
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Oct 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.
The investigator's goal is to promote a plant-based diet amongst the underserved urban population of Louisville with the help of educational aids and the provision of affordable resources.
Detailed description
Primary care clinic patients who screen positive for food insecurity between 2021-2023 will be eligible for this study (~200 patients). Patients will be recruited by one of four means: during standard clinic visits, or via phone, Electronic Medical Record message, or mail. Registry of patients will be de-identified and list of identifiers will be stored separately from the data set. Data will be stored on password protected computers only available to select research staff. Investigators will utilize a preamble in lieu of informed consent.
The primary outcome will be to measure the readiness of patients to adhere to a plant-based diet. Investigators will assess readiness using Food Neophobia inventory and will perform a brief Diet Inventory at simultaneous timepoints. Education surrounding benefits and easy ways to increase plant-based eating will be distributed to all participating patients. Enrollment in a local income-based subsidized Community Supported Agriculture share (weekly farm produce box during growing season) will be offered to all patients. Patients can opt into this service, and we will track which patients enroll. Before, during, and after the Community Sponsored Agriculture produce time period, Food Neophobia and Diet Inventory will be reassessed.
Adherence to plant-based eating between the patients who received access to subsidized food and education versus those who received education alone will be evaluated. Qualitative open-ended feedback will be obtained at all time points.
The secondary outcomes are to measure weight loss, reduction in blood pressure, and improvement in hemoglobin A1C and lipid profile wherever applicable.
Statistical significance is not attempting to be reached, but rather the associations between food neophobia and ability to change diet will be evaluated, as well as other qualitative open-ended feedback.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free/Subsidized Community Supported Agriculture (CSA) produce along with education. | Experimental | Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.Patients who self-elect to enroll in subsidized/free Community-supported agriculture produce shares will also receive Education on the benefits of a plant-based diet. |
| Education Alone | Active comparator | Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.Patients will receive educational information about the benefits of plant-based eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 and older screening as food insecure since 2021
- Patients willing to complete survey data
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Implementing free/subsidized agricultural produce to encourage a plant-based diet.Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce. | Other | Education Alone, Free/Subsidized Community Supported Agriculture (CSA) produce along with education. |
Primary outcome
Food Neophobia
Time frame: 1 year
Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Diet Inventory
Time frame: 1 year
Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.
3 secondary outcomes
Reduction in blood pressure
Time frame: 1 year
Improvement in lipid profile
Time frame: 1 year
Weight Loss
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. Patient identifiers will be visible to Principal investigator and Co-Investigatory and kept in separate password-protected database. Other study investigators will see Individual Participant Data with identifiers removed.
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.
Anuja Abhyankar contact
Erin Murphy principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementing free/subsidized agricultural produce to encourage a plant-based diet. in people with Food Neophobia and Food Preferences, run by University of Louisville 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: status not confirmed, as of the sponsor's last update on 1 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Murphy (5025922388, erin.murphy@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Neophobia (time frame: 1 year). The study lists 2 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 1 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.