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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR019487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Our long-term goal is to transform rural residents' management of T2DM. This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | ||
| Healthy Food Delivery Intervention | Experimental | 9000 calorie / week food box |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Food Delivery Intervention | Behavioral | Each weekly food box will include ~9,000 calories of food, equivalent to the amount the average household receives prorated per week from an average Arkansas food pantry. The boxes will be designed by a registered dietitian. The boxes will follow ADA's Create Your Plate method consistent with the meal pattern promoted in the American College of Physicians (ACP) DSMES. The foods will also reflect Feeding America's Detailed Foods to Encourage framework, developed by nutrition experts and food bank staff to represent USDA dietary guidelines with healthy food that can be made available by food banks. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage. | Baseline to immediate post-intervention (approx. 18 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R Long, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS - North Central | Batesville | Arkansas | 72501 | United States | ||
| UAMS - East |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458560 | Derived | Short E, Selig JP, Felix HC, Painter J, McElfish PA, Rowland B, Ammerman AS, Bounds K, Henske J, Hudson JS, Li J, Young SG, Long CR. Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol. Contemp Clin Trials. 2024 May;140:107491. doi: 10.1016/j.cct.2024.107491. Epub 2024 Mar 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2024 | Dec 10, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Helena |
| Arkansas |
| 72390 |
| United States |
| UAMS - Northeast | Jonesboro | Arkansas | 72401 | United States |
| UAMS - South | Magnolia | Arkansas | 71753 | United States |
| D004700 | Endocrine System Diseases |