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临床试验/NCT06614920
NCT06614920招募中不适用

Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access

University of Miami1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月9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
100
试验地点
1
主要终点
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables

研究概览

简要总结

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be all ages 0-99 (all arms)
  • Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
  • Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.

排除标准

  • Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
  • Families who are not actively receiving outpatient primary care (all arms).

研究组 & 干预措施

Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)

Experimental

Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education), we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age (detailed in Arm 2 description).

Participants in Arm 1 only (dual intervention) will be provided with a food prescription at the end of each class. Participants will bring this food prescription to Village FREEdge, where it will function as a voucher. Each voucher will allow for participants to pick up enough food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day).

干预措施: Plant-Based Food Provision (with or without food prescription) (Other)

Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)

Experimental

Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education), we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age (detailed in Arm 2 description).

Participants in Arm 1 only (dual intervention) will be provided with a food prescription at the end of each class. Participants will bring this food prescription to Village FREEdge, where it will function as a voucher. Each voucher will allow for participants to pick up enough food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day).

干预措施: Plant-Based Nutrition Education (Other)

Plant-Based Nutrition Education Only (single intervention 1)

Experimental

Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education) and Arm 2 (single intervention 1- nutrition education only) we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age. If participants are 14 years old or older, they will listen to a 45-minute plant-based nutrition lecture and engage in a 45-minute interactive activity, including but not limited to plant-based meal preparation. Participants younger than 14 years old will be guided through age-appropriate interactive activities for the full 1.5-2 hours in a nearby classroom.

干预措施: Plant-Based Nutrition Education (Other)

结局指标

主要结局

Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables

时间窗: Up to 1 year

The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed fruits and vegetables.

Number of Servings of Unprocessed and Minimally Processed Whole Grains

时间窗: Up to 1 year

The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed whole grains.

Number of Servings of Unprocessed and Minimally Processed Legumes

时间窗: Up to 1 year

The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed legumes.

Number Servings of Unprocessed and Minimally Processed Nuts/Seeds

时间窗: Up to 1 year

The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed nuts/seeds.

次要结局

  • Presence of Food Insecurity(Up to 1 year)
  • Change in Plant-Based Nutrition Knowledge of Participants(Up to 1 year)

研究者

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

Azaria Lewis

Internal Medicine-Pediatric Resident Physician

University of Miami

研究点 (1)

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