肾脏健康：吃得好，活得好
“肾脏健康：吃得好，活得好”：一项通过健康合作伙伴提供的营养和同理心支持来减少肾脏损伤和早期 CKD 进展的计划
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.
研究概览
地位
条件
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Texas
-
Houston、Texas、美国、77026
- Harris Health System's Outpatient Center
-
Houston、Texas、美国、77047
- Harris Health System's Martin Luther King Jr. Health Center
-
Houston、Texas、美国、77054
- Harris Health System's Smith Clinic
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1: Intervention + usual care
|
At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes:
Those allocated to the intervention arm will receive a welcome call from the Program Staff to provide further details and expectations about the program (such as delivery details and schedule). Those allocated to the control arm will receive an SMS text that informs them of their arm allocation, what to expect and a phone number to call for questions.
Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency:
|
|
其他：Arm 2: Educational materials + usual care
|
At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes:
Those allocated to the intervention arm will receive a welcome call from the Program Staff to provide further details and expectations about the program (such as delivery details and schedule). Those allocated to the control arm will receive an SMS text that informs them of their arm allocation, what to expect and a phone number to call for questions. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urine albumin:creatinine ratio (UACR)
大体时间：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. |
Baseline, 3 months, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hemoglobin A1C
大体时间：Baseline, 3 months, 6 months
|
Finger stick point-of-care portable device. Measures the average blood sugar levels over the past 3 months with a result in %. Higher A1C levels indicate poorer glycemic control and higher risk of diabetes complications. |
Baseline, 3 months, 6 months
|
|
Blood pressure (systolic/diastolic)
大体时间：Baseline, 3 months, 6 months
|
Direct measurement with automatic blood pressure cuff. |
Baseline, 3 months, 6 months
|
|
Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10
大体时间：Baseline, 3 months, 6 months
|
30-day food frequency questionnaire (screener) that asks for frequency of intake in the past month (per month, per week, or per day) of 28 items such as cereal, red meat, fruits and vegetables. This study includes four food items linked to kidney health (and mostly acid-inducing): eggs, chicken/turkey, fish, and cheese. Questions are asked in the same fashion as the other questions in the tool. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake from the Dietary Screener Questionnaire, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported per fruits and vegetables as cup equivalents/day. |
Baseline, 3 months, 6 months
|
|
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
大体时间：Baseline, 3 months, 6 months
|
Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms). |
Baseline, 3 months, 6 months
|
|
Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)
大体时间：Baseline, 3 months, 6 months
|
Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). The sum of responses to each item yields a total score that screens for depression and its severity: not depressed (0-2), mild (3-5), moderate (6-8), and severe (9-12). |
Baseline, 3 months, 6 months
|
|
Loneliness measured by scores on the 3-item UCLA Loneliness Scale
大体时间：Baseline, 3 months, 6 months
|
Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness. |
Baseline, 3 months, 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Social engagement as measured by the Lubben Social Network scale 6-item
大体时间：Baseline, 6 months
|
Self-administered. The LSNS-6 is a self-report measure of social engagement with family and friends. The sum of the all items yields a total score that ranges between 0 and 30, with a higher score indicating more social engagement. |
Baseline, 6 months
|
|
Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire
大体时间：Baseline, 6 months
|
Self-administered. Answers are on a 0-10 sliding scale, except for one open-ended ranking question. Increases in item scores represent linear increases in the dimension measured. It contains 9 questions addressing the individual's cognitive perceptions, control over illness, beliefs about the effectiveness of treatment, experience of symptoms and emotional aspects. To better tailor it to the study population, "illness" was replaced by "kidney problem". And one question about perceived impact of food on disease was added to tailor it to the intervention. |
Baseline, 6 months
|
|
General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
大体时间：Baseline, 6 months
|
Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health. |
Baseline, 6 months
|
|
Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
大体时间：Baseline, 6 months
|
Self-administered. Self-report assessment of access to food in the past 30 days. The sum of affirmative responses to the six questions in the module yields the household's raw score on the scale. Scores can range from 0 to 6, with higher scores indicating lower food security. |
Baseline, 6 months
|
|
Estimated Glomerular Filtration Rate (eGFR)
大体时间：As available 18 months before enrollment in the study and 15 months after study participation ends
|
Obtained from Electronic Health Records. Any lab result available from 18 months prior to and 15 month post enrollment date will be obtained for study participants. |
As available 18 months before enrollment in the study and 15 months after study participation ends
|
|
Changes in diet quality as estimates of individual mean dietary intake and frequency of dairy consumption
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Food group of dairy is reported as cup equivalents/day. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as estimates of individual mean dietary intake of added sugars
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported added sugars as teaspoon equivalents/day. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as estimates of individual mean dietary intake and frequency of whole grains
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported whole grains as ounce equivalents/day. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as estimates of individual mean dietary intake of fiber
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported fiber as g/day. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as estimates of individual mean dietary intake of calcium
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported calcium as mg/day. |
Baseline, 3 months, 6 months
|
|
Changes in diet quality as frequency of red and processed meat consumption
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. And reported red meat and processed meat as frequencies (times per day). |
Baseline, 3 months, 6 months
|
|
Changes in frequency and intake of eggs
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its acid-inducing properties in chronic kidney disease. Reported as frequencies only (times per day) and amount. |
Baseline, 3 months, 6 months
|
|
Changes in frequency and intake of chicken/turkey
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its acid-inducing properties in chronic kidney disease. Reported as frequencies only (times per day). |
Baseline, 3 months, 6 months
|
|
Changes in frequency and intake of fish
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its association with reduced CVD risk. Reported as frequencies only (times per day). |
Baseline, 3 months, 6 months
|
|
Changes in type of cheese consumption when reported
大体时间：Baseline, 3 months, 6 months
|
Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Soft vs. hard cheese types added for the acid-inducing properties of hard cheese in chronic kidney disease. Reported as type associated with dairy consumption. |
Baseline, 3 months, 6 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Maninder Kahlon, PhD、University of Texas at Austin
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.