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临床试验/NCT07221045
NCT07221045招募中不适用

PhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina

North Carolina State University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Fruit and vegetable intake

研究概览

简要总结

Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic disparities, such as inadequate access to affordable healthy food. Thus, this project. Thus, this study, PhytoRx Families, an innovative produce prescription (Prx) program, addresses health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes.

详细描述

Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic inequities, such as inadequate access to affordable healthy food. Thus, this project, PhytoRx Families, an innovative produce prescription (Prx) program, will address health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related outcomes. This study will define impact on FV intake using the ASA24 dietary recall (primary outcome) among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade). The study will also explore the impact of PhytoRxF on cardiovascular health-related outcomes (blood pressure, glycated hemoglobin (HbA1C), height, weight (BMI calculated)). Finally the study will examine the change in healthcare utilization among PhytoRxF participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent in English or Spanish (speaking, reading, writing)
  • An adult (18 years of age or older) who's a parent or caregiver of a child ages 8 to 14 years old or a child ages 8 to 14 years old
  • Served at participating clinic in a county where the program is being implemented (Goldsboro Pediatrics, Bertie County Rural Health Association, and Roanoke Chowan Community Health in Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
  • Living in a county where the program is being implemented (Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
  • Free living to the extent they are able to receive and use a box of fresh produce and participate in direct nutrition education classes
  • Willing and able to provide written consent and participate in all study activities.

排除标准

  • Adults not at risk of food insecurity
  • Adults, who are not parents nor caregivers of a child 8 to 14 years
  • Adults who do not want to or could not fully participate (e.g., an adult family member with advanced kidney disease with severe dietary restrictions).

结局指标

主要结局

Fruit and vegetable intake

时间窗: Baseline and end of study at 16 weeks

Measured by ASA24 dietary recall

次要结局

  • Skin carotenoids(Baseline and end of study at 16 weeks)
  • Diet quality(Baseline and end of study at 16 weeks)
  • Self-efficacy for Healthy Eating(Baseline and end of study at 16 weeks)
  • Food security status(Baseline and end of study at 16 weeks)
  • Nutrition security status(Baseline and end of study at 16 weeks)
  • Blood pressure(Baseline and end of study at 16 weeks)
  • Hemoglobin A1C(Baseline and end of study at 16 weeks)
  • Body Mass Index(Baseline and end of study at 16 weeks)
  • Food-related Parenting Practices(Baseline and end of study at 16 weeks)
  • Barriers and Facilitators to Fruit and Vegetable Consumption(Baseline to end of study at 16 weeks)
  • Body Mass Index-For-Age Percentile(Baseline and end of study at 16 weeks)

研究者

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

Basheerah Enahora

Assistant Professor

North Carolina State University

研究点 (2)

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