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| Name | Class |
|---|---|
| Food Bank of the Rockies | UNKNOWN |
| National Kidney Foundation, United States | OTHER |
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The goal of this pilot clinical trial is primarily learn if produce boxes improve clinical outcomes among Veterans with kidney disease and food or nutrition insecurity. Secondly, the study will capture Veterans qualitative perspectives, experience, and engagement through semi-structured interviews.
This study aims to address kidney health disparities by implementing and evaluating a Food is/as Medicine intervention tailored for up to 20 Veterans with CKD. These community-engaged efforts seek to better understand the interrelation of nutrition, health, and socioeconomic factors affecting kidney related or patient-centered, along with quantitative clinical, outcomes. The long-term goal of this work is to develop and demonstrate community-based interventions or efforts that improve dietary adherence/quality, reduce food insecurity, improve nutrition security, and enhance kidney health outcomes while providing sustainability, scalable insights for broader public/kidney health and VA healthcare policies or programs.
Objectives:
Objective 1: Evaluate the short-term impact of culturally and medically tailored food boxes and produce (3-month mid-point):
Objective 2: Assess the longitudinal impact and perceived future long-term impact of food boxes (6- month endpoint):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VET FAM Product Box and Nutrition Education | Experimental | Veterans with kidney disease stages 3b-4 will receive weekly produce boxes through the Food Bank of the Rockies Food for Health program. Boxes include fresh/canned fruits, vegetables, and other items. Participants will also receive nutrition education materials and brief support to encourage preparation and consumption of the provided foods over the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VET FAM Product Box and Nutrition Education | Other | Food boxes and nutrition education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic Blood Pressure | Baseline (0-months), 3-months, and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine | Measure of kidney function | Baseline (0-months), 3-months, 6-months |
| Estimated Glomerular Filtration Rate (eGFR) | Measure of kidney function |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative participant perspectives, experiences, and engagement themes | Qualitative semi-structured recorded interviews capturing participant perspectives for themes. | 3-months and 6-months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis M Perez, PhD, RD | Contact | 720-467-0757 | luis.perez2@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Luis M Perez, PhD, RD | US Department of Veterans Affairs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center | Recruiting | Aurora | Colorado | 80045 | United States |
Veterans Affairs data may only be shared with VA approved investigators and per VA policy.
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Baseline (0-months), 3-months, and 6-months |
| Blood urea nitrogen (BUN) | A waster product formed from protein breakdown, also filtered by the kidneys | Baseline (0-months), 3-months, 6-months |
| Albumin | A protein that may indication kidney damage, inflammation, nutritional status or other measures | Baseline (0-months), 3-months, 6-months |
| HbA1c | Glycosylated hemoglobin A1c | Baseline (0-months), 3-months, and 6-months |
| Kidney disease quality of life (KDQOL) | Kidney disease quality of life measured by the KDQOL short form instrument | Baseline (0-months), 3-months, 6-months |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |