Reducing Chronic Kidney Disease Burden in an Underserved Population

NCT03832166 | Completed DMC

• 1 other identifier: 1R21DK113440-01A1
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD; ESRD

Keywords

CKD; Low Income; Diet; Fruits and Vegetables

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Changes from baseline in systolic and diastolic Blood pressure 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

• Changes from baseline in Blood glucose 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

Study Arms (2)

Fruits and Vegetables Only

EXPERIMENTAL

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

Fruits and Vegetables and Cook

EXPERIMENTAL

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; Other: Cooking

Interventions

Fruits and Vegetables OTHER

Fruits and vegetables delivery, once/week for 24 weeks

Fruits and Vegetables Only; Fruits and Vegetables and Cook

Cooking OTHER

Nutrition education and cooking instruction class, one class/week for 6 weeks

Also known as: The Happy Kitchen

Fruits and Vegetables and Cook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75210, United States

Location

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MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Fruit; Vegetables; Cooking

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food Handling; Food Industry; Industry; Technology, Industry, and Agriculture

Study Officials

• Donald Wesson, MD, MBA

  Baylor RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized two group study

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start: January 24, 2019
• Primary Completion: June 13, 2020
• Study Completion: July 14, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 6 mths of outcome publication

Locations

US (1)