Feeding America Intervention Trial for Health--Diabetes Mellitus (FAITH-DM)
2020年5月14日 更新者：University of California, San Francisco
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
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。
学习地点
-
-
California
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Oakland、California、美国、94614
- Alameda County Community Food Bank
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San Francisco、California、美国、94143
- University of California San Francisco
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Michigan
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Detroit、Michigan、美国、48207
- Gleaners Community Food Bank of Southeastern Michigan
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Texas
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Houston、Texas、美国、77029
- Houston Food Bank
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-
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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immediate Intervention
Participants randomized to the Intervention Arm will immediately begin a four-component intervention.
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Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations.
The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
|
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有源比较器：Waitlist Control
Participants randomized to the Waitlist Control arm will receive no intervention for six months, after which time they will begin a modified, four-component intervention.
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Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations.
The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
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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 from Baseline HbA1c at 6 Months
大体时间：6 months
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Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
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6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Dietary Intake
大体时间：6 months and 12 months
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Brief fruit & vegetable dietary screener
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6 months and 12 months
|
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Change from Baseline Health Care Utilization
大体时间：6 months and 12 months
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Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
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6 months and 12 months
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Change from Baseline Diabetes Distress
大体时间：6 months and 12 months
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Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale
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6 months and 12 months
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Change from Baseline Hypoglycemic events
大体时间：6 months and 12 months
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Self-reported hypoglycemic events over the previous 4 weeks, both any events and number of events, and self-reported severe hypoglycemic episodes, both any events and number of events
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6 months and 12 months
|
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Change from Baseline Depressive symptoms
大体时间：6 months and 12 months
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PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
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6 months and 12 months
|
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Change from Baseline Medication Adherence
大体时间：6 months and 12 months
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Morisky Medication Adherence Scale (4 items)
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6 months and 12 months
|
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Food vs medicine trade-offs
大体时间：6 months and 12 months
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Three self-reported questions
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6 months and 12 months
|
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Change from Baseline Food security status
大体时间：6 months and 12 months
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6-item version of the USDA's Core Food Security Survey Module
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6 months and 12 months
|
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Change from Baseline Food stability
大体时间：6 months and 12 months
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Two items assessing adequacy of food resources to last the entire month
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6 months and 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Diabetes Self-Efficacy
大体时间：6 months and 12 months
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8-item scale of diabetes-specific self-efficacy
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6 months and 12 months
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Change from Baseline Diabetes Self-Care
大体时间：6 months and 12 months
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Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care
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6 months and 12 months
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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。
调查人员
- 首席研究员：Hilary K Seligman, MD MAS、University of California, San Francisco
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
- Seligman HK, Levi R, Ridberg R, Smith M, Hills N, Waxman E. Impact of Enhanced Food Pantry Services on Food Security among Adults with Diabetes Using a Crossover Study Design. Curr Dev Nutr. 2022 Feb 10;6(4):nzac021. doi: 10.1093/cdn/nzac021. eCollection 2022 Apr.
- Smith M, Rosenmoss S, Seligman HK. Point-of-Care Hemoglobin A1C Testing System in Community Settings: Challenges, Opportunities, and Measurement Characteristics. Prog Community Health Partnersh. 2020;14(3):327-335. doi: 10.1353/cpr.2020.0038.
- Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.
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)
2015年10月1日
初级完成 (实际的)
2017年10月31日
研究完成 (实际的)
2017年10月31日
研究注册日期
首次提交
2015年10月2日
首先提交符合 QC 标准的
2015年10月5日
首次发布 (估计)
2015年10月6日
研究记录更新
最后更新发布 (实际的)
2020年5月18日
上次提交的符合 QC 标准的更新
2020年5月14日
最后验证
2020年5月1日
更多信息
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.