Reducing Chronic Kidney Disease Burden in an Underserved Population
- Conditions
- ESRDCKD
- Interventions
- Other: Fruits and VegetablesOther: Cooking
- Registration Number
- NCT03832166
- Lead Sponsor
- Baylor Research Institute
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fruits and Vegetables and Cook Cooking 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. Fruits and Vegetables Only Fruits and Vegetables 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 Fruits and Vegetables 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.
- Primary Outcome Measures
Name Time Method 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 dietary fat intake at 6 weeks and 6 months Baseline; 6 weeks; 6 months Track changes in fat (g) intake via ASA24 food diary
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
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
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months Baseline; 6 weeks; 6 months Primary surrogate marker of eGFR
- Secondary Outcome Measures
Name Time Method 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 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
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 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
Trial Locations
- Locations (1)
Baylor Research Institute
🇺🇸Dallas, Texas, United States