此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

将教育、农产品供应和社区转诊联系起来以改善糖尿病护理 (LINK)

2026年11月2日 更新者：Joshua Joseph, MD、Ohio State University

This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter

Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.

Primary and secondary outcomes will be collected at baseline, 3 and 6 months.

研究类型

介入性

注册 (估计的)

568

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University Wexner Medical Center
        • 首席研究员：
          • Joshua J Joseph, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Type 2 Diabetes based on American Diabetes Association Criteria
  • Hemoglobin A1c ≥ 7.5%
  • Screen Positive on 2-item Food Security Screener

Exclusion Criteria:

  • Unwilling to Attest to Release of Information to Mid-Ohio Food Collective

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Mid Ohio Food Farmacy

The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
行为的：Mid-Ohio Food Farmacy

The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
实验性的：Mid-Ohio Food Farmacy + Cooking for Diabetes

The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention.
行为的：Mid-Ohio Food Farmacy + Cooking for Diabetes

The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention.
实验性的：Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.
行为的：Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.
实验性的：Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub

The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.
行为的：Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub

The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Hemoglobin A1c
大体时间：3 months

measures average blood sugar levels over the past 3 months
3 months

次要结果测量

结果测量
措施说明
大体时间
Change in Hemoglobin A1c
大体时间：6 months

measures average blood sugar levels over the past 3 months
6 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
大体时间：3 months

Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.
3 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
大体时间：6 months

Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.
6 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
大体时间：3 months

Food security will be assessed using the 18-item U.S. Household Food Security Survey Module.

For households with one or more children:

  • Raw score zero-High food security
  • Raw score 1-2-Marginal food security
  • Raw score 3-7-Low food security
  • Raw score 8-18-Very low food security

For households with no child present:

  • Raw score zero-High food security
  • Raw score 1-2-Marginal food security
  • Raw score 3-5-Low food security
  • Raw score 6-10-Very low food security
3 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
大体时间：6 months

Food security will be assessed using the 18-item U.S. Household Food Security Survey Module.

For households with one or more children:

  • Raw score zero-High food security
  • Raw score 1-2-Marginal food security
  • Raw score 3-7-Low food security
  • Raw score 8-18-Very low food security

For households with no child present:

  • Raw score zero-High food security
  • Raw score 1-2-Marginal food security
  • Raw score 3-5-Low food security
  • Raw score 6-10-Very low food security
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ohio State University

合作者

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

调查人员

  • 首席研究员：Joshua Joseph, MD, MPH、Ohio State University
  • 首席研究员：Daniel Walker, PhD、Ohio State University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年2月6日

初级完成 (估计的)

2027年3月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2022年7月21日

首先提交符合 QC 标准的

2022年7月21日

首次发布 (实际的)

2022年7月25日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2022H0045
  • R01DK132403 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.

IPD 共享时间框架

Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.

IPD 共享访问标准

Requests will be reviewed by the project investigators (PI). In accordance with NIH policies and procedures regarding data use and data sharing, user registration will be required to access the files. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistributions of the data to third parties, and proper acknowledgement of the data resource. Any presentations, abstracts, or publications must include an acknowledgement/reference of the LINK research team.

The requesting researcher(s) will be notified that they may only use the data for the purposes for which the data were requested and only by the individuals listed in the request. The requesting researcher(s) will be responsible for notifying the PI upon completion of analysis indicating the way the data were destroyed.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅