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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
142
Fruits and vegetables delivery, once/week for 24 weeks
Nutrition education and cooking instruction class, one class/week for 6 weeks
Baylor Research Institute
Dallas, Texas, United States
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Primary surrogate marker of eGFR
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline; 6 weeks; 6 months
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)
Time frame: Baseline; 6 weeks; 6 months
Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline; 6 weeks; 6 months
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