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To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F&V for consumption, the latter being done for all F&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F&V only (F&V Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruits and Vegetables Only | Experimental | This group will receive a prescribed amount of free fruits and vegetables (F & V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 18 weeks with minimal contact |
|
| Fruits and Vegetables and Cook | Experimental | In addition to the prescribed amount of free F&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruits and Vegetables | Other | Fruits and vegetables delivery, once/week for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months | Primary surrogate marker of eGFR | Baseline; 6 weeks; 6 months |
| Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months | Measure of renal damage | Baseline; 6 weeks; 6 months |
| Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months | Track changes in fruit and vegetable intake via ASA24 food diary | Baseline; 6 weeks; 6 months |
| Changes from baseline in dietary fat intake at 6 weeks and 6 months | Track changes in fat (g) intake via ASA24 food diary | Baseline; 6 weeks; 6 months |
| Changes from baseline in caloric intake at 6 weeks and 6 months | Track changes in total caloric(kcal) intake via ASA24 food diary | Baseline; 6 weeks; 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months | Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD) | Baseline; 6 weeks; 6 months |
| Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Wesson, MD, MBA | Baylor RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Research Institute | Dallas | Texas | 75210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26885959 | Background | Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available. | |
| Background | System USRD. Annual Data Report 2015: Epidemiology of Kidney Disease in the United States. Washington DC: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2015 | ||
| 25125737 |
Not provided
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All IPD that underlie results in a publication
Data will be available within 6 mths of outcome publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 17, 2022 | |
| Reset | Nov 9, 2022 |
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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 | Jan 21, 2019 | Feb 1, 2019 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 17, 2022 | Nov 9, 2022 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D005638 | Fruit |
| D014675 | Vegetables |
| D003296 | Cooking |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Prospective, randomized two group study
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| Cooking | Other | Nutrition education and cooking instruction class, one class/week for 6 weeks |
|
|
Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk |
| Baseline; 6 weeks; 6 months |
| Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months | Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk | Baseline; 6 weeks; 6 months |
| Changes from baseline in Blood glucose at 6 weeks and 6 months | Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk | Baseline; 6 weeks; 6 months |
| Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months | Measure body mass index(lb/inches squared) to assess CVD risk | Baseline; 6 weeks; 6 months |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005511 |
| Food Handling |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |