Reducing Chronic Kidney Disease Burden in an Underserved Population

Study Overview
=================
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).

Official Title
-----------------
A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults

Conditions
-----------------
CKD, ESRD

Intervention / Treatment
-----------------
* Other: Fruits and Vegetables
* Other: Cooking


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized two group study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruits and Vegetables Only<br>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 | Other: Fruits and Vegetables<br>* Fruits and vegetables delivery, once/week for 24 weeks<br>|
| Experimental: Fruits and Vegetables and Cook<br>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. | Other: Fruits and Vegetables<br>* Fruits and vegetables delivery, once/week for 24 weeks<br>Other: Cooking<br>* Nutrition education and cooking instruction class, one class/week for 6 weeks<br>* Other names: The Happy Kitchen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Low Income, Diet, Fruits and Vegetables