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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK079626 | U.S. NIH Grant/Contract | View source |
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Stored specimens unavailable due to being depleted for COVID-19 research. Study converted to retrospective observational study of clinic patients diabetes trends using EMR data.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose control is less successful in this population who are also often food insecure. Food assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure PLWH who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates.
The objective of this investigation is to develop and assess a study protocol to evaluate the impact of food assistance on diabetes-related health outcomes in food insecure people living with HIV (PLWH). Compared to the general population, PLWH have increased risk for type 2 diabetes and worse glycemic control when using similar pharmaceutical treatments. Interventions to improve diet quality could thus have a clinically meaningful impact on diabetes treatment in this population. However, many PLWH are food insecure and rely on food assistance to meet basic nutrition needs. This proposal will determine the feasibility of a protocol to evaluate diabetes-related health outcomes in food insecure PLWH and diabetes who receive high protein, high dietary fiber food boxes from Birmingham AIDS Outreach. The study will consist of retrospective analysis of electronic medical record data and stored specimens, and prospective cross-sectional analysis of food security and diet quality in PLWH who do versus those who do not receive the food boxes.
Specific Aim 1: To determine the feasibility of recruiting, enrolling, and collecting dietary intake data from people living with HIV who are food insecure.
Specific Aim 2: To compare changes over twelve months in glycemic control, food security, and diet quality in B-FED participants compared to non-participating 1917 clinic patients.
This proposal aligns with the UAB Diabetes Research Center's goal to facilitate development of new methods to treat diabetes and its complications. The investigators will determine the effect size for scale-up of larger, longer-term assessment through an NIDDK-R18 grant to evaluate the real-world impact of B-FED on glycemic control and food security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-FED | Clients of the Birmingham AIDS Outreach Food and Education Delivery (B-FED) program who are also patients at the 1917 Clinic. |
| |
| non B-FED | Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food assistance | Other | This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program. |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure. | We will track the ability to recruit and enroll eligible participants in the study. | 1 year |
| Change in diabetes-related health outcomes as measured by hemoglobin A1c. | Six months after program enrollment, B-FED participants will have improved glycemic control (lower hemoglobin A1c). Value will be measured using stored blood samples. | 1 year |
| Compare food security among groups using the Food Security Questionnaire. | B-FED participants will report a higher prevalence of food security compared to clinic patients who do not participate in the program. This will be assessed at 1 time point using the validated 2-item Food Security Questionnaire to classify participants as food secure, low food security, or very low food security. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be patients at the UAB 1917 Clinic who are diagnosed with HIV and type 2 diabetes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35294 | United States |
IPD will only be available to the study PI and research coordinator. Only deidentified data will be shared with other investigators.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2019 | Apr 10, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D063105 | Food Assistance |
| ID | Term |
|---|---|
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
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Stored serum will be analyzed for markers of glycemic control: glucose, insulin, glycosylated hemoglobin, and fructosamine.
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| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004472 |
| Health Care Economics and Organizations |