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临床试验/NCT07748286
NCT07748286已完成不适用

Evaluating the Impact of a Comprehensive Food as Medicine Intervention on Glycemic Control at Two Large Academic Medical Centers

Indiana University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
HbA1c Change at 6 to 9 months

研究概览

简要总结

The primary purpose of this study is to determine if the implementation of a food as medicine program would improve clinical outcomes when integrated into routine care at two large academic hospitals.

  1. Determine if the FRESH Program's methods of addressing food insecurity improves clinical outcomes, reduces emergency room visits, and reduces hospital admissions for patients with diabetes, cardiovascular disease, surgery, and/or recent COVID-19 hospital admission.
  2. Determine the feasibility and scalability of the FRESH Program nutrition intervention within two separate health systems in order to inform future state and federal policies governing reimbursement for nutritional interventions that improve food insecurity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • some form of diabetes
  • receiving care at an Eskenazi FQHC or the Indiana Health East Washington Clinic

排除标准

  • 未提供

研究组 & 干预措施

Eskenazi Health Diabetes Clinics

Active Comparator

This arm included patients living with diabetes who were receiving care at Eskenazi Health.

干预措施: Food as Medicine Eskenazi (Behavioral)

Indiana Health East Washington Diabetes Clinic

Active Comparator

This arm includes patients living with diabetes and receiving diabetes care at Indiana Health's East Washington Clinic.

干预措施: Indiana Health NourishedRX (Behavioral)

结局指标

主要结局

HbA1c Change at 6 to 9 months

时间窗: 9 months

Change in HbA1c from baseline and at 6.1 to 9 months after intervention

次要结局

  • HbA1c change at other time points(1 year)

研究者

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

Sonak Pastakia

Adjunct Professor of Medicine

Indiana University

研究点 (1)

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