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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- CKD
- Sponsor
- Baylor Research Institute
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
- Status
- Completed
- Last Updated
- 5 years ago
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).
Investigators
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
Outcomes
Primary Outcomes
Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
Time Frame: Baseline; 6 weeks; 6 months
Measure of renal damage
Changes from baseline in dietary fat intake at 6 weeks and 6 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline; 6 weeks; 6 months
Primary surrogate marker of eGFR
Secondary Outcomes
- Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in Blood glucose at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)