Clinical trial NCT03832166: Reducing Chronic Kidney Disease Burden in an Underserved Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CKD
ESRD
Keywords: CKD
Low Income
Diet
Fruits and Vegetables
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized two group study
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in dietary fat intake at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in caloric intake at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
Secondary outcomes:
measure: Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in Blood glucose at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
measure: Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
timeFrame: Baseline; 6 weeks; 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor RI
name: Donald Wesson, MD, MBA
role: PRINCIPAL_INVESTIGATOR
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