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OpenTrials
Completed

NCT Number: NCT03832166

Reducing Chronic Kidney Disease Burden in an Underserved Population

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Research Institute

Dallas, Texas, 75210, United States

About this study

"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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruits and Vegetables

Other

Fruits and vegetables delivery, once/week for 24 weeks

Cooking

Other

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

Other names: The Happy Kitchen

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months

    Time frame: Baseline; 6 weeks; 6 months

    Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)

  2. Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months

    Time frame: Baseline; 6 weeks; 6 months

    Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk

  3. Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months

    Time frame: Baseline; 6 weeks; 6 months

    Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk

  4. Changes from baseline in Blood glucose at 6 weeks and 6 months

    Time frame: Baseline; 6 weeks; 6 months

    Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk

  5. Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months

    Time frame: Baseline; 6 weeks; 6 months

    Measure body mass index(lb/inches squared) to assess CVD risk

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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