Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fruits and Vegetables
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.
干预措施: Fruits and Vegetables (Other)
Wait List Control
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.
结局指标
主要结局
Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Track changes in fruit and vegetable intake via ASA24 dietary recall food diary.
Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Measure changes in systolic/diastolic blood pressure (mmHg) to assess cardiovascular disease (CVD) risk.
Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Measure of renal damage.
次要结局
- Metabolomics will be used to profile how changes in diet effects disease risk.(Baseline and 6 Weeks)