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Chronic Kidney DiseasesNCT05970341

Kidney Health: Eat Well, Live Well

A study testing 1. Welcome package, 2. Welcome information (phone or text) and 3. Produce delivery + Recipes customized to produce in people with Chronic Kidney Diseases, run by University of Texas at Austin at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
1. Welcome package, 2. Welcome information (phone or text) and 3. Produce delivery + Recipes customized to produce
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
3 sitesUnited States
Study dates
6 Dec 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Harris Health System's Outpatient Center

    Houston, Texas, 77026

  • Harris Health System's Martin Luther King Jr. Health Center

    Houston, Texas, 77047

  • Harris Health System's Smith Clinic

    Houston, Texas, 77054

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
1. Welcome package, 2. Welcome information (phone or text), 3. Produce delivery + Recipes customized to produce, 4. E-gift cards to a grocery store of choice, 5. Personalized practical & emotional support through a dedicated health partner
Keywords
phone calls, Telehealth, Fruits and vegetables, Produce, Home delivery, grocery vouchers, gift cards, Community-based trial, Proteinuria, Diet, mental health
Medical subject headings
Renal Insufficiency, Chronic, Proteinuria, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1. Welcome packageBehavioural

    At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes:

    • educational and motivational written materials (about such topics as CKD and healthy eating for early CKD stages)
    • a collection of recipes featuring kidney-friendly vegetables

  • 2. Welcome information (phone or text)Behavioural

    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.

  • 3. Produce delivery + Recipes customized to produceBehavioural

    • Content: Bags with kidney-friendly produce will include 2 vegetables sufficient for 2 meals for 4 people, 1 type of fruit, and 1 dried fruit. The total cost is estimated at USD 20, excluding delivery, for prices in June 2022.
    • Delivery: Bags will be delivered to the participant's preferred location (e.g. home or work) and period of the day (e.g., morning, evening).
    • Recipes: SMS texts will precede each delivery to share an URL to recipes customized to the items being delivered, and to inform of an upcoming produce bag, its content.
    • Frequency:
    1. Weeks 1-2 (2 weeks): No bags delivered.
    2. Weeks 3-10 (8 weeks): Delivered weekly, for a total of 8 bags.
    3. Weeks 11-18 (8 weeks): Delivered every two weeks, for a total of 4 bags.
    4. Weeks 19-26 (8 weeks): No bags delivered.

  • 4. E-gift cards to a grocery store of choiceBehavioural

    Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency:

    1. Weeks 1-6: No e-gift card.
    2. Week 7: One card of USD 30.00 value.
    3. Week 11 \& 15: One card of USD 40.00, for a total of USD 80.00.
    4. Week 19 \& 23: One card of USD 60.00, for a total of USD 120.00.

  • 5. Personalized practical & emotional support through a dedicated health partnerBehavioural

    • Each participant is assigned a program staff ("dedicated health partner") who call them briefly (15 min or so) over the phone for empathy-based support on the participant's health journey, and practical suggestions for shopping and food preparation.
    • The Health Partner will share periodically via SMS text a curated list of evidence-based, trustworthy online educational resources.
    • Health partners are not trained to answer medical or health-related questions and will not provide medical guidance or advice of any kind. For such questions, they will encourage participants to contact the clinic or physician.
    • Frequency:
    1. Weeks 1-2 (2 weeks): No calls.
    2. Weeks 3-7 (4 weeks): 2 calls a week, for a total of 8 calls.
    3. Weeks 8-26 (18 weeks): 1 call every 2 weeks, for a total of 10. But during weeks 7, 11, and 19, participants will be given the choice to keep at 1x/week or decrease to 1x every 4 weeks.
Study groups in NCT05970341
Study groupRoleWhat they receive
Arm 1: Intervention + usual careExperimental1. 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
Receives: Behavioral: 1. Welcome package; Behavioral: 2. Welcome information (phone or text); Behavioral: 3. Produce delivery + Recipes customized to produce; Behavioral: 4. E-gift cards to a grocery store of choice; Behavioral: 5. Personalized practical & emotional support through a dedicated health partner
Arm 2: Educational materials + usual careOther1. Welcome package 2. Welcome information: SMS/Text
Receives: Behavioral: 1. Welcome package; Behavioral: 2. Welcome information (phone or text)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine albumin:creatinine ratio (UACR)

    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.

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (7)

  1. Hemoglobin A1C

    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.

    Measured: Baseline, 3 months, 6 months

  2. Blood pressure (systolic/diastolic)

    Direct measurement with automatic blood pressure cuff.

    Measured: Baseline, 3 months, 6 months

  3. Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10

    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.

    Measured: Baseline, 3 months, 6 months

  4. Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption

    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.

    Measured: Baseline, 3 months, 6 months

  5. Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)

    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).

    Measured: Baseline, 3 months, 6 months

  6. Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)

    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).

    Measured: Baseline, 3 months, 6 months

  7. Loneliness measured by scores on the 3-item UCLA Loneliness Scale

    Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start6 Dec 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970341
Sponsor's protocol ID
STUDY00002253
Status last verified
Sep 2026
First submitted
24 Jul 2023
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 1. Welcome package, 2. Welcome information (phone or text) and 3. Produce delivery + Recipes customized to produce in people with Chronic Kidney Diseases, run by University of Texas at Austin at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine albumin:creatinine ratio (UACR) (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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Kidney Health: Eat Well, Live Well (NCT05970341) | AzTrials