Clinical trial NCT05970341: Kidney Health: Eat Well, Live Well
Official title: "Kidney Health: Eat Well, Live Well": A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition & Empathetic Support From a Health Partner
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: phone calls
Telehealth
Fruits and vegetables
Produce
Home delivery
grocery vouchers
gift cards
Community-based trial
Proteinuria
Diet
mental health
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Harris Health
First posted: 2023-08-01
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Urine albumin:creatinine ratio (UACR)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: Baseline, 3 months, 6 months
measure: Blood pressure (systolic/diastolic)
timeFrame: Baseline, 3 months, 6 months
measure: Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption
timeFrame: Baseline, 3 months, 6 months
measure: Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline, 3 months, 6 months
measure: Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)
timeFrame: Baseline, 3 months, 6 months
measure: Loneliness measured by scores on the 3-item UCLA Loneliness Scale
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Social engagement as measured by the Lubben Social Network scale 6-item
timeFrame: Baseline, 6 months
measure: Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire
timeFrame: Baseline, 6 months
measure: General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
timeFrame: Baseline, 6 months
measure: Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
timeFrame: Baseline, 6 months
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: As available 18 months before enrollment in the study and 15 months after study participation ends
measure: Changes in diet quality as estimates of individual mean dietary intake and frequency of dairy consumption
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as estimates of individual mean dietary intake of added sugars
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as estimates of individual mean dietary intake and frequency of whole grains
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as estimates of individual mean dietary intake of fiber
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as estimates of individual mean dietary intake of calcium
timeFrame: Baseline, 3 months, 6 months
measure: Changes in diet quality as frequency of red and processed meat consumption
timeFrame: Baseline, 3 months, 6 months
measure: Changes in frequency and intake of eggs
timeFrame: Baseline, 3 months, 6 months
measure: Changes in frequency and intake of chicken/turkey
timeFrame: Baseline, 3 months, 6 months
measure: Changes in frequency and intake of fish
timeFrame: Baseline, 3 months, 6 months
measure: Changes in type of cheese consumption when reported
timeFrame: Baseline, 3 months, 6 months
Locations:
city: Houston
country: United States
facility: Harris Health System's Outpatient Center
state: Texas
city: Houston
country: United States
facility: Harris Health System's Martin Luther King Jr. Health Center
state: Texas
city: Houston
country: United States
facility: Harris Health System's Smith Clinic
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: