A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
研究概览
简要总结
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F&V for consumption, the latter being done for all F&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
详细描述
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F&V only (F&V Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).
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
- 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
- 是
入选标准
- •Willingness to participate in 6 month F&V study
- •Positive urine dipstick.
- •African American (self declared) race
- •Access to 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 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
研究组 & 干预措施
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.
干预措施: Fruits and Vegetables (Other)
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
干预措施: Fruits and Vegetables (Other)
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.
干预措施: Cooking (Other)
结局指标
主要结局
Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
时间窗: Baseline; 6 weeks; 6 months
Measure of renal damage
Changes from baseline in dietary fat intake at 6 weeks and 6 months
时间窗: Baseline; 6 weeks; 6 months
Track changes in fat (g) intake via ASA24 food diary
Changes from baseline in caloric intake at 6 weeks and 6 months
时间窗: Baseline; 6 weeks; 6 months
Track changes in total caloric(kcal) intake via ASA24 food diary
Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
时间窗: Baseline; 6 weeks; 6 months
Track changes in fruit and vegetable intake via ASA24 food diary
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
时间窗: Baseline; 6 weeks; 6 months
Primary surrogate marker of eGFR
次要结局
- Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in Blood glucose at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)
- Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months(Baseline; 6 weeks; 6 months)