Cardiorenal Protective Diet (CPD)

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Hypertension; Chronic Kidney Diseases; Cardiovascular Diseases

Treatments: Other: Fruits and Vegetables

Study type: Interventional

Funder types: Other

Identifiers

NCT04117204

018-095

Details and patient eligibility

About

This study will evaluate providing fruits and vegetables in a sustainable community care clinic setting, in addition to routine medical care, to individuals with CKD (Stage 2-4) on CKD and CVD risk, or cardio-renal risk factors. Further, metabolomics profiling will be used to study how change in the diet affects disease risk. Data from this study will be published in peer-reviewed journals, presented at national conferences, and will serve as pilot data to guide and strengthen applications for NIH funding.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willingness to participate in a 3-month F&V study.
• Positive urine dipstick (Proteinuria and/or Albumin-to-Creatinine Ratio >=10).
• African-American (self-declared) race
• A current diagnosis of hypertension or a current blood pressure reading consistent with hypertension (SBP >= 140 and/or DBP >=90).
• Access to the 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 a kidney transplant.
• Pregnant or planning to become pregnant in the next 6 months.
• Baseline urine potassium > 60mEq/g creatinine
• Negative diagnosis of hypertension or blood pressure reading (SBP <140 or DBP <90).
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Fruits and Vegetables

Experimental group

Description:

This group will receive a prescribed amount of free fruits and vegetables (F\&V) for 6 weeks of 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 6 weeks with minimal contact.

Treatment:

Other: Fruits and Vegetables

Wait List Control

No Intervention group

Description:

This group will not receive a prescribed amount of free fruits and vegetables (F\&V) for 12 weeks. They will serve as the control group. After 12 weeks of control and data comparisons, they will be given 12 weeks of vouchers with minimal contact.