Reducing Chronic Kidney Disease Burden in an Underserved Population

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: ESRD; CKD

Treatments: Other: Fruits and Vegetables; Other: Cooking

Study type: Interventional

Funder types: Other

Identifiers

NCT03832166

1R21DK113440-01A1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

142 participants in 2 patient groups

Fruits and Vegetables Only

Experimental group

Description:

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

Treatment:

Other: Fruits and Vegetables

Fruits and Vegetables and Cook

Experimental group

Description:

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.

Treatment:

Other: Fruits and Vegetables

Other: Cooking