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| Name | Class |
|---|---|
| Feeding America | OTHER |
| Laura and John Arnold Foundation | OTHER |
| Urban Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Participants randomized to the Intervention Arm will immediately begin a four-component intervention.
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| Waitlist Control | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing and Monitoring of Blood Glucose Levels | Other | Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline HbA1c at 6 Months | Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Dietary Intake | Brief fruit & vegetable dietary screener | 6 months and 12 months |
| Change from Baseline Health Care Utilization | Communication with primary care provider requesting dates of service, service levels, and diagnosis codes |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Diabetes Self-Efficacy | 8-item scale of diabetes-specific self-efficacy | 6 months and 12 months |
| Change from Baseline Diabetes Self-Care | Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary K Seligman, MD MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda County Community Food Bank | Oakland | California | 94614 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35415385 | Derived | 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. | |
| 33416608 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2016 |
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| Primary care coordination | Other | Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider. |
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| Diabetes-appropriate food packages | Other | Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly. |
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| Diabetes self-management education | Behavioral | 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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| 6 months and 12 months |
| Change from Baseline Diabetes Distress | Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale | 6 months and 12 months |
| Change from Baseline Hypoglycemic events | 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 | 6 months and 12 months |
| Change from Baseline Depressive symptoms | PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality) | 6 months and 12 months |
| Change from Baseline Medication Adherence | Morisky Medication Adherence Scale (4 items) | 6 months and 12 months |
| Food vs medicine trade-offs | Three self-reported questions | 6 months and 12 months |
| Change from Baseline Food security status | 6-item version of the USDA's Core Food Security Survey Module | 6 months and 12 months |
| Change from Baseline Food stability | Two items assessing adequacy of food resources to last the entire month | 6 months and 12 months |
| 6 months and 12 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Gleaners Community Food Bank of Southeastern Michigan | Detroit | Michigan | 48207 | United States |
| Houston Food Bank | Houston | Texas | 77029 | United States |
| 30024798 | Derived | 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. |
| Dec 5, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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