CKD, ESRD
Conditions
Keywords
CKD, Low Income, Diet, Fruits and Vegetables
Brief summary
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.
Detailed description
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).
Interventions
Fruits and vegetables delivery, once/week for 24 weeks
OTHERCooking
Nutrition education and cooking instruction class, one class/week for 6 weeks
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomized two group study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willingness to participate in 6 month F&V study * Positive urine dipstick. * African American (self declared) race * Access to internet via personal computer or mobile device * Ability to read and write in English
Exclusion criteria
* Negative urine dipstick * Currently receiving dialysis or needing dialysis (stage 5 Kidney disease) * Have received or need kidney transplant * Pregnant or plan to become pregnant in the next 6 months * Baseline urine potassium \> 60 mEq/g creatinine * Nephrotic proteinuria demonstrated on urine ACR measurement * Lacking access to the internet via personal computer or mobile device * Unable to read or write in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in caloric intake at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Track changes in total caloric(kcal) intake via ASA24 food diary |
| Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Primary surrogate marker of eGFR |
| Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure of renal damage |
| Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Track changes in fruit and vegetable intake via ASA24 food diary |
| Changes from baseline in dietary fat intake at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Track changes in fat (g) intake via ASA24 food diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD) |
| Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk |
| Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk |
| Changes from baseline in Blood glucose at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk |
| Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months | Baseline; 6 weeks; 6 months | Measure body mass index(lb/inches squared) to assess CVD risk |
Countries
United States
Outcome results
None listed