Reducing Chronic Kidney Disease Burden in an Underserved Population

ESRD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832166
• Other study ID #: 1R21DK113440-01A1
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 14, 2020
• Est. primary completion date: June 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CKD
• ESRD

Intervention

Other:
• Fruits and Vegetables
Fruits and vegetables delivery, once/week for 24 weeks
• Cooking
Nutrition education and cooking instruction class, one class/week for 6 weeks

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months	Primary surrogate marker of eGFR	Baseline; 6 weeks; 6 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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