University of Louisville Ambulatory Internal Medicine Resident Clinic
Louisville, Kentucky, 40202, United States
Location status: Recruiting
NCT Number: NCT06090409
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Louisville, Kentucky, 40202, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.
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.
Time frame: 1 year
Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.
Time frame: 1 year
Systolic and diastolic blood pressure will be recorded when done per Standard of Care.
Time frame: 1 year
measure of hemoglobin A1C will be recorded when done per Standard of Care.
Time frame: 1 year
measure of weight will be recorded when done per Standard of Care.
Contact information is provided by the study sponsor or research team.
University of Louisville
Other
Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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