"Kidney Health: Eat Well, Live Well": A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition & Empathetic Support From a Health Partner
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- Urine albumin:creatinine ratio (UACR)
研究概览
简要总结
This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.
详细描述
This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the likelihood of kidney injury progression.
The program components were design to reduce barriers to a) eating healthier, kidney-friendly foods through the direct provision of fruits and vegetables, grocery store e-gift cards, kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the role of healthy eating in slowing its progression through educational materials; and c) social connection through empathetic relational phone calls and SMS texts from a dedicated "Health Partner".
Over a period of 6 months (26 weeks), participants randomized to the intervention arm will receive:
- kidney-friendly produce (fruits and vegetables) delivered at their preferred location
- recipes and tips on food preparation tailored to the produce
- grocery store electronic gift cards
- educational materials on CKD and disease management
- personalized practical and emotional support through a dedicated Health Partner
Researchers will see if participation in the program (intervention) reduces markers of kidney injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet (particularly fruits and vegetables intake) and mental health when compared to usual care (control).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Research staff responsible for biomedical data collection at the sites are blinded to the participant's allocation group. Surveys are primarily self-administered on an electronic mobile device (e.g., tablet, laptop). For participants who require help reading and/or using the device, survey data will be collected via structured interview.
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
- •Adult (18 years of age or older)
- •Primary care visit at either one of the three partner clinics from Harris Health [Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin Luther King Jr. Health Center (MLK)] and a primary care patient within Harris Health System
- •Have had at least 1 visit in the past 18 months with prior history in the clinic (i.e., not first visit)
- •Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular Filtration Rate (eGFR) ≥ 30 and <90 mL/min/1.73 m2 OR CDK 1 or undiagnosed with urine Albumin Creatinine Ratio ≥ 30 mg/g
- •Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L
- •English or Spanish speaking
- •Ability to participate in the program at least 6 months
- •Ability to clean, prepare, refrigerate/freeze food products that are given to them
- •Have access to receive SMS text messages
- •Location of preferred produce bag delivery within an available delivery zone
排除标准
- •CKD 4, ESRD or on dialysis.
- •Taking certain medications chronically (more than twice a week for 90 days) that may interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs (NSAIDs), as self-reported during enrollment screening
- •Taking mineralocorticoid receptor antagonists
- •Taking Warfarin
- •Diagnosis of any specific kidney conditions (such as polycystic kidney disease, glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study participation as determined by physician
- •Medical history of organ transplant that would contraindicate study participation as determined by physician
- •Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment
- •Diagnostic of heart failure conditions Class IV in the New York Heart Association (NYHA) functional classification
- •Had myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- •Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks prior to enrolment
- •On active hospice care as self-reported during enrollment screening
- •Diagnosis of active malignancy requiring treatment that would contraindicate study participation as determined by physician
- •Has decompensated cirrhosis as determined by physician
- •Cognitive impairment that would contraindicate study participation as self-reported during enrollment screening
结局指标
主要结局
Urine albumin:creatinine ratio (UACR)
时间窗: Baseline, 3 months, 6 months
Marker of kidney damage and a useful predictor of cardiovascular (CV) events in adults. Uses spot urine to estimate 24-hour urine albumin excretion. UACR \> 30 mg/g indicates kidney damage.
次要结局
- Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption(Baseline, 3 months, 6 months)
- Blood pressure (systolic/diastolic)(Baseline, 3 months, 6 months)
- Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10(Baseline, 3 months, 6 months)
- Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)(Baseline, 3 months, 6 months)
- Hemoglobin A1C(Baseline, 3 months, 6 months)
- Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)(Baseline, 3 months, 6 months)
- Loneliness measured by scores on the 3-item UCLA Loneliness Scale(Baseline, 3 months, 6 months)
研究者
Maninder Kahlon
Associate Professor, Population Health
University of Texas at Austin