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临床试验/NCT06090409
NCT06090409招募中不适用

Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population

University of Louisville1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Food Neophobia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients age 18 and older screening as food insecure since 2021
  • •Patients willing to complete survey data

排除标准

  • 未提供

研究组 & 干预措施

Education Alone

Active Comparator

Patients will receive educational information about the benefits of plant-based eating.

干预措施: Implementing free/subsidized agricultural produce to encourage a plant-based diet. (Other)

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.

干预措施: Implementing free/subsidized agricultural produce to encourage a plant-based diet. (Other)

结局指标

主要结局

Food Neophobia

时间窗: 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

时间窗: 1 year

Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.

次要结局

  • Weight Loss(1 year)
  • Reduction in blood pressure(1 year)
  • Improvement in lipid profile(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Murphy

Assistant Professor, M.D.

University of Louisville

研究点 (1)

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