Food As Medicine to Reduce CKD Burden in Health Disparity Populations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months
研究概览
简要总结
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.
详细描述
Chronic kidney disease (CKD) impacts approximately 1/7 Americans, who experience asymptomatic progressive CKD leading to catastrophic complications, including kidney failure and death, and this R01 study will extend our previous R21 work to screen, identify , and intervene with culinary medicine philosophy within a community-based setting. The overall goals of the research study are to evaluate (1) urine albumin to creatinine ratio outcomes, (2) secondary endpoints including cardiovascular disease (CVD) measurements (i.e., systolic and diastolic blood pressure, body mass index, hemoglobin A1c, lipids), and (3) dietary adherence and change as well as nutrition knowledge and efficacy. This work will determine whether base-producing fruit and vegetables with or without culinary medicine improves CKD outcomes and associated CVD risk in lower socioeconomic community settings to inform future multi-site trials and population level implementation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women of age ≥ 18 years and able to give consent;
- •willingness to participate in a 12-month study;
- •elevated albumin to creatinine ratio (ACR) (≥ 30 mg/g) determined by point-of-care urine dipstick during health screen;
- •Reside in a low-income area or visit a food pantry due to food insecurity
排除标准
- •whose urine dipstick does not indicate micro- or macro-albuminuria (ACR <30 mg/g),
- •currently receiving dialysis or need dialysis,
- •have received or need a kidney transplant,
- •pregnant or plan to become pregnant in the next 12 months,
- •baseline urine potassium > 60 mEq/g creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit/vegetable were paired with kidney-protective drugs,
- •urine ACR values indicate nephrotic proteinuria, and
- •CKD stage 5 demonstrated by elevated estimated glomerular filtration rate (eGFR) obtained during baseline measures.
研究组 & 干预措施
Fruits and Vegetables (FV) Only (Control)
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.
Fruits and Vegetables + Nutrition and Cooking education
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.
干预措施: Culinary Medicine Nutrition and Cooking Education (Behavioral)
结局指标
主要结局
Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months
时间窗: Baseline (enrollment), 6 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 6- months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for End-Stage Kidney Disease (ESKD).
Change in Urine Albumin to Creatinine Ratio at 12 months
时间窗: Baseline (enrollment), 12 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 12-months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for ESKD.
次要结局
- Change from Baseline in Systolic and Diastolic Blood Pressure at 6 months(Baseline (enrollment), 6 months)
- Change from Baseline in Systolic and Diastolic Blood Pressure at 12 Months(Baseline (enrollment), 12 months)
- Change from Baseline in Glycated Hemoglobin (HbA1c) at 6 months(Baseline (enrollment), 6 Months)
- Change from Baseline in Glycated Hemoglobin (HbA1c) at 12 Months(Baseline (enrollment), 12 months)
- Change from Baseline in Body Mass Index (BMI) at 6 Months(Baseline (enrollment), 6 Months)
- Change from Baseline in Body Mass Index (BMI) at 12 Months(Baseline (enrollment), 12 months)
- Change in LDL Cholesterol (LDL-C) Level From Baseline to 6 months(Baseline (enrollment), 6 Months)
- Change in LDL Cholesterol (LDL-C) Level From Baseline to 12 Months(Baseline (enrollment), 12 months)
- Change in HDL Cholesterol (HDL-C) Level From Baseline to 6 months(Baseline (enrollment), 6 Months)
- Change in HDL Cholesterol (HDL-C) Level From Baseline to 12 Months(Baseline (enrollment), 12 months)
- Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 6 months(Baseline (enrollment), 6 Months)
- Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 12 Months(Baseline (enrollment), 12 months)
研究者
Sarah Messiah
Professor
University of Texas Southwestern Medical Center