Feeding America Intervention Trial for Health--Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 8
- 主要终点
- Change from Baseline HbA1c at 6 Months
研究概览
简要总结
The Feeding America Intervention Trial for Health-Diabetes Mellitus (FAITH-DM) is a randomized, controlled study of the implementation of a diabetes intervention in food pantry settings.
详细描述
For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated complications. This education is often difficult to access for highly vulnerable and marginalized adults in the United States. Furthermore, foods for a diabetic diet are often out of reach for food insecure households. The purpose of this study is to determine the extent to which food banks and food pantries can help reach this population with effective DSME, food, and access to primary health care. The investigators' primary outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control group of food pantry clients living with uncontrolled type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Food pantry client at one of three participating food banks: Alameda County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern Michigan (Detroit, MI), Houston Food Bank, (Houston, TX)
- •Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing
- •Reliable mode of contact (either phone or address)
- •English or Spanish verbal fluency
- •18 years of age or older
- •Intent to remain in the study area for at least the next 12 months
- •Willingness to participate in intervention
排除标准
- •Type 1 diabetes
- •Pregnant or less than 6 weeks post-partum
- •Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to interfere with administration of the survey or participation in the intervention
- •Household member already enrolled in the study
结局指标
主要结局
Change from Baseline HbA1c at 6 Months
时间窗: 6 months
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
次要结局
- Change from Baseline Dietary Intake(6 months and 12 months)
- Change from Baseline Health Care Utilization(6 months and 12 months)
- Change from Baseline Food stability(6 months and 12 months)
- Change from Baseline Diabetes Distress(6 months and 12 months)
- Change from Baseline Hypoglycemic events(6 months and 12 months)
- Change from Baseline Depressive symptoms(6 months and 12 months)
- Change from Baseline Medication Adherence(6 months and 12 months)
- Food vs medicine trade-offs(6 months and 12 months)
- Change from Baseline Food security status(6 months and 12 months)