Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 568
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes based on American Diabetes Association Criteria
- •Hemoglobin A1c ≥ 7.5%
- •Screen Positive on 2-item Food Security Screener
排除标准
- •Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
研究组 & 干预措施
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.
干预措施: Mid-Ohio Food Farmacy (Behavioral)
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.
干预措施: Mid-Ohio Food Farmacy + Cooking for Diabetes (Behavioral)
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.
干预措施: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub (Behavioral)
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.
干预措施: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: 3 months
measures average blood sugar levels over the past 3 months
次要结局
- Change in Hemoglobin A1c(6 months)
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module(6 months)
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale(6 months)
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale(3 months)
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module(3 months)
研究者
Joshua Joseph, MD
Associate Professor of Medicine
Ohio State University