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临床试验/NCT07011251
NCT07011251已完成不适用

Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults

Alison Gustafson2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2024年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
159
试验地点
2
主要终点
Change systolic blood pressure

研究概览

简要总结

Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of Hypertension in last 12 months
  • Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
  • English or Spanish speaking
  • No plans to move from the area for at least 1 year
  • Willing and able to accept text messages
  • Free living to the extent that participant has control over dietary intake
  • Willing and able to provide written informed consent and participate in all study activities.

排除标准

  • Participant in weight research intervention in last 12 months
  • Considering bariatric surgery in the next year or prior bariatric surgery
  • Lack of safe, stable residence and ability to store meals
  • Lack of telephone which can receive text messages
  • Pregnancy/breastfeeding or intended pregnancy in the next year
  • Known drug or alcohol misuse in the past 2 years

结局指标

主要结局

Change systolic blood pressure

时间窗: Baseline and week 12

captured from the electronic medical record

Change diastolic blood pressure

时间窗: Baseline and week 12

captured from the electronic medical record

次要结局

  • Change in Dietary Intake(Baseline and week 12)
  • Change in food insecurity(Baseline and week 12)
  • Change in Nutrition Security(Baseline and week 12)

研究者

发起方
Alison Gustafson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alison Gustafson

Professor

University of Kentucky

研究点 (2)

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