Food As Medicine to Reduce CKD Burden in Health Disparity Populations
(FAME-CKD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease.
If the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours.
Participation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.
Who Is on the Research Team?
Donald Wesson, MD
Principal Investigator
University of Texas Southwestern Medical Center
Sarah Messiah, PhD
Principal Investigator
University of Texas Southwestern Medical Center
Heather Kitzman, PhD
Principal Investigator
Parkland Health
Are You a Good Fit for This Trial?
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive the same free base-producing as the FV Only group plus 12 weekly group nutrition and cooking education classes delivered through the UTSW Culinary Medicine program. Classes include hands-on cooking instruction, nutrition education, goal setting, behavioral strategies, and skill-building activities designed to improve healthy eating behaviors, self-efficacy, and motivation.
This group will receive a prescribed amount of free (at no charge) base-producing FV for 12 months through pick-up at one of two Brother Bills Helping Hand (BBHH) sites. BBHH clients pick up groceries weekly from either their main West Dallas campus or the South Dallas Community Market. This calculated FV amount averages 2-3 cups of base-producing FV daily. The FV Only group is considered standard care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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