Kidney Health: Eat Well, Live Well
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: 1. Welcome packageBehavioral: 2. Welcome information (phone or text)Behavioral: 3. Produce delivery + Recipes customized to produceBehavioral: 4. E-gift cards to a grocery store of choiceBehavioral: 5. Personalized practical & emotional support through a dedicated health partner
- Registration Number
- NCT05970341
- Lead Sponsor
- University of Texas at Austin
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 330
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Educational materials + usual care 2. Welcome information (phone or text) 1. Welcome package 2. Welcome information: SMS/Text Arm 1: Intervention + usual care 5. Personalized practical & emotional support through a dedicated health partner 1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner Arm 2: Educational materials + usual care 1. Welcome package 1. Welcome package 2. Welcome information: SMS/Text Arm 1: Intervention + usual care 2. Welcome information (phone or text) 1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner Arm 1: Intervention + usual care 3. Produce delivery + Recipes customized to produce 1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner Arm 1: Intervention + usual care 4. E-gift cards to a grocery store of choice 1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner Arm 1: Intervention + usual care 1. Welcome package 1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner
- Primary Outcome Measures
Name Time Method Urine albumin:creatinine ratio (UACR) 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.
- Secondary Outcome Measures
Name Time Method Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption 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.
Blood pressure (systolic/diastolic) Baseline, 3 months, 6 months Direct measurement with automatic blood pressure cuff.
Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10 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.Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7) 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).
Hemoglobin A1C 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.
Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8) 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).
Loneliness measured by scores on the 3-item UCLA Loneliness Scale 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.
Trial Locations
- Locations (3)
Harris Health System's Outpatient Center
🇺🇸Houston, Texas, United States
Harris Health System's Martin Luther King Jr. Health Center
🇺🇸Houston, Texas, United States
Harris Health System's Smith Clinic
🇺🇸Houston, Texas, United States