Reducing Chronic Kidney Disease Burden in an Underserved Population
NCT ID: NCT03832166
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2019-01-24
2020-07-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Fruits and Vegetables Only
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
Fruits and Vegetables
Fruits and vegetables delivery, once/week for 24 weeks
Fruits and Vegetables and Cook
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Donald Wesson, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Baylor RI
Locations
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Baylor Research Institute
Dallas, Texas, United States
Countries
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References
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Kitzman H, Montgomery AH, Khan M, Mamun A, Tecson KM, Allison P, Simoni J, Wesson DE. The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial. Kidney Med. 2023 Oct 23;5(12):100736. doi: 10.1016/j.xkme.2023.100736. eCollection 2023 Dec.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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