xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970341</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002253</org_study_id>
      <nct_id>NCT05970341</nct_id>
    </id_info>
    <brief_title>Kidney Health: Eat Well, Live Well</brief_title>
    <official_title>&quot;Kidney Health: Eat Well, Live Well&quot;: A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition &amp; Empathetic Support From a Health Partner</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Harris Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Texas at Austin</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26&#xD;
        weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine&#xD;
        ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as&#xD;
        PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in&#xD;
        community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2&#xD;
        or 3 and not on kidney replacement therapies) compared to educational materials and usual&#xD;
        care alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, we test a community-based program aimed at supporting adults with early-stage&#xD;
        chronic kidney disease to change their eating habits to reduce the likelihood of kidney&#xD;
        injury progression.&#xD;
  &#xD;
        The program was design to reduce barriers to a) eating healthier, kidney-friendly foods&#xD;
        through the direct provision of fruits and vegetables, grocery store e-gift cards,&#xD;
        kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the&#xD;
        role of healthy eating in slowing its progression through educational materials; and c)&#xD;
        social connection through empathetic relational phone calls and SMS texts from a dedicated&#xD;
        &quot;Health Partner&quot;.&#xD;
  &#xD;
        Over a period of 6 months (26 weeks), participants randomized to the intervention arm will&#xD;
        receive:&#xD;
  &#xD;
          -  kidney-friendly produce (fruits and vegetables) delivered at their preferred location&#xD;
  &#xD;
          -  recipes and tips on food preparation tailored to the produce&#xD;
  &#xD;
          -  grocery store electronic gift cards&#xD;
  &#xD;
          -  educational materials on CKD and disease management&#xD;
  &#xD;
          -  personalized practical and emotional support through a dedicated Health Partner&#xD;
  &#xD;
        Researchers will see if participation in the program (intervention) reduces markers of kidney&#xD;
        injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet&#xD;
        (particularly fruits and vegetables intake) and mental health when compared to usual care&#xD;
        (control).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Urine albumin:creatinine ratio (UACR)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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 &gt; 30 mg/g indicates kidney damage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1C</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure (systolic/diastolic)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Direct measurement with automatic blood pressure cuff.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food intake</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>One 24h recall collected via structured interview by trained staff using NIH's ASA24®</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diet quality as Healthy Eating Index scores (HEI-2015)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>The overall HEI-2015 score is made up of 13 components that reflect the different food groups and key recommendations in the 2015-2020 Dietary Guidelines for Americans for ages 2 years and older. The overall HEI scores range from 0 to 100, derived from the 24h recalls. Higher scores indicate that the set of foods better aligns with key dietary recommendations from the Dietary Guidelines for Americans.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Loneliness measured by scores on the 3-item UCLA Loneliness Scale</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Social engagement as measured by the Lubben Social Network scale 6-item</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>Self-administered. 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, &quot;illness&quot; was replaced by &quot;kidney problem&quot;. And one question about perceived impact of food on disease was added to tailor to the intervention. 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.</description>
    </other_outcome>
    <other_outcome>
      <measure>General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12)</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>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 is the household's raw score on the scale. Higher scores indicate greater food insecurity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Estimated Glomerular Filtration Rate (eGFR)</measure>
      <time_frame>As available 18 months before enrollment in the study and 15 months after study participation ends</time_frame>
      <description>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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">330</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Welcome package&#xD;
  Welcome information: telephone call&#xD;
  Produce delivered at their choice of time and location + Recipes customized to produce&#xD;
  E-gift cards to a grocery store of choice&#xD;
  Personalized practical, emotional &amp; educational support through a dedicated health partner</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2: Educational materials + usual care</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Welcome package&#xD;
  Welcome information: SMS/Text</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>1. Welcome package</intervention_name>
      <description>At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes:&#xD;
  educational and motivational written materials (about such topics as CKD and healthy eating for early CKD stages)&#xD;
  a collection of recipes featuring kidney-friendly vegetables</description>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
      <arm_group_label>Arm 2: Educational materials + usual care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>2. Welcome information (phone or text)</intervention_name>
      <description>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).&#xD;
  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.</description>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
      <arm_group_label>Arm 2: Educational materials + usual care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>3. Produce delivery + Recipes customized to produce</intervention_name>
      <description>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.&#xD;
  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).&#xD;
  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.&#xD;
  Frequency:&#xD;
  Weeks 1-2 (2 weeks): No bags delivered.&#xD;
  Weeks 3-10 (8 weeks): Delivered weekly, for a total of 8 bags.&#xD;
  Weeks 11-18 (8 weeks): Delivered every two weeks, for a total of 4 bags.&#xD;
  Weeks 19-26 (8 weeks): No bags delivered.</description>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>4. E-gift cards to a grocery store of choice</intervention_name>
      <description>Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency:&#xD;
  Weeks 1-6: No e-gift card.&#xD;
  Week 7: One card of USD 30.00 value.&#xD;
  Week 11 &amp; 15: One card of USD 40.00, for a total of USD 80.00.&#xD;
  Week 19 &amp; 23: One card of USD 60.00, for a total of USD 120.00.</description>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>5. Personalized practical &amp; emotional support through a dedicated health partner</intervention_name>
      <description>Each participant is assigned a program staff (&quot;dedicated health partner&quot;) 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.&#xD;
  The Health Partner will share periodically via SMS text a curated list of evidence-based, trustworthy online educational resources.&#xD;
  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.&#xD;
  Frequency:&#xD;
  Weeks 1-2 (2 weeks): No calls.&#xD;
  Weeks 3-7 (4 weeks): 2 calls a week, for a total of 8 calls.&#xD;
  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.</description>
      <arm_group_label>Arm 1: Intervention + usual care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (18 years of age or older)&#xD;
  &#xD;
            -  Primary care patient at either one of the three partner clinics from Harris Health&#xD;
               [Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin&#xD;
               Luther King Jr. Health Center (MLK)]&#xD;
  &#xD;
            -  Have had at least 1 visit in the past 18 months with prior history in the clinic&#xD;
               (i.e., not first visit)&#xD;
  &#xD;
            -  Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular Filtration&#xD;
               Rate (eGFR) ≥ 30 and &lt;90 mL/min/1.73 m2 *OR* CDK stage 1 (diagnosed or not) with urine&#xD;
               Albumin Creatinine Ratio ≥ 30 mg/g&#xD;
  &#xD;
            -  Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L&#xD;
  &#xD;
            -  If prescribed, on maximum dose and adherent to ACE or ARB medication for at least 4&#xD;
               weeks before enrolment (visit 1)&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Ability to participate in the program at least 6 months&#xD;
  &#xD;
            -  Ability to clean, prepare, refrigerate/freeze food products that are given to them&#xD;
  &#xD;
            -  Have access to receive SMS text messages&#xD;
  &#xD;
            -  Location of preferred produce bag delivery within an available delivery zone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  CKD 4, ESRD or on dialysis.&#xD;
  &#xD;
            -  Taking certain medications chronically (more than twice a week for 90 days) that may&#xD;
               interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
  &#xD;
            -  Taking mineralocorticoid receptor antagonists&#xD;
  &#xD;
            -  Taking Warfarin&#xD;
  &#xD;
            -  Diagnosis of any specific kidney conditions (such as polycystic kidney disease,&#xD;
               glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic&#xD;
               antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study&#xD;
               participation as determined by physician&#xD;
  &#xD;
            -  Medical history of organ transplant that would contraindicate study participation as&#xD;
               determined by physician&#xD;
  &#xD;
            -  Received immunotherapy for primary or secondary kidney disease within 6 months prior&#xD;
               to enrolment&#xD;
  &#xD;
            -  Diagnostic of heart failure conditions Class IV in the New York Heart Association&#xD;
               (NYHA) functional classification&#xD;
  &#xD;
            -  Diagnosis of diabetes mellitus type 1&#xD;
  &#xD;
            -  Had myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA)&#xD;
               within 12 weeks prior to enrolment that would contraindicate study participation as&#xD;
               determined by physician&#xD;
  &#xD;
            -  Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks prior to&#xD;
               enrolment&#xD;
  &#xD;
            -  Life expectancy is less than 2 years, such as in the case of certain medical&#xD;
               conditions as determined by physician&#xD;
  &#xD;
            -  Diagnosis of active malignancy requiring treatment that would contraindicate study&#xD;
               participation as determined by physician&#xD;
  &#xD;
            -  Has decompensated cirrhosis&#xD;
  &#xD;
            -  Cognitive impairment that would contraindicate study participation as determined by&#xD;
               physician&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maninder Kahlon, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas at Austin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Courtney Mulligan, MA</last_name>
      <phone>512-522-4349</phone>
      <email>Courtney.Mulligan@austin.utexas.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nicole Clark, MBA</last_name>
      <phone>210-316-5443</phone>
      <email>nicole.clark@austin.utexas.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Harris Health System's Outpatient Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77026</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Harris Health System's Martin Luther King Jr. Health Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77047</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Harris Health System's Smith Clinic</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77054</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
      <investigator_full_name>Maninder Kahlon</investigator_full_name>
      <investigator_title>Associate Professor, Population Health</investigator_title>
    </responsible_party>
    <keyword>phone calls</keyword>
    <keyword>Telehealth</keyword>
    <keyword>Fruits and vegetables</keyword>
    <keyword>Produce</keyword>
    <keyword>Home delivery</keyword>
    <keyword>grocery vouchers</keyword>
    <keyword>gift cards</keyword>
    <keyword>Community-based trial</keyword>
    <keyword>Proteinuria</keyword>
    <keyword>Diet</keyword>
    <keyword>mental health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 15, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT05970341/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970341
  org study id: STUDY00002253
  nct id: NCT05970341
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  In this study, we test 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 was 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).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.
  primary purpose: Health Services Research
  masking: Double (Investigator, Outcomes Assessor)
  masking description: 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.
  measure: Urine albumin:creatinine ratio (UACR)
  time frame: Baseline, 3 months, 6 months
  description: 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.
  measure: Hemoglobin A1C
  time frame: Baseline, 3 months, 6 months
  description: 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.
  measure: Blood pressure (systolic/diastolic)
  time frame: Baseline, 3 months, 6 months
  description: Direct measurement with automatic blood pressure cuff.
  measure: Food intake
  time frame: Baseline, 3 months, 6 months
  description: One 24h recall collected via structured interview by trained staff using NIH's ASA24®
  measure: Diet quality as Healthy Eating Index scores (HEI-2015)
  time frame: Baseline, 3 months, 6 months
  description: The overall HEI-2015 score is made up of 13 components that reflect the different food groups and key recommendations in the 2015-2020 Dietary Guidelines for Americans for ages 2 years and older. The overall HEI scores range from 0 to 100, derived from the 24h recalls. Higher scores indicate that the set of foods better aligns with key dietary recommendations from the Dietary Guidelines for Americans.
  measure: Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
  time frame: Baseline, 3 months, 6 months
  description: 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).
  measure: Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8)
  time frame: Baseline, 3 months, 6 months
  description: 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).
  measure: Loneliness measured by scores on the 3-item UCLA Loneliness Scale
  time frame: Baseline, 3 months, 6 months
  description: Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.
  measure: Social engagement as measured by the Lubben Social Network scale 6-item
  time frame: Baseline, 6 months
  description: 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.
  measure: Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire
  time frame: Baseline, 6 months
  description: Self-administered. 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 to the intervention. 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.
  measure: General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
  time frame: Baseline, 6 months
  description: 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.
  measure: Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
  time frame: Baseline, 6 months
  description: 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 is the household's raw score on the scale. Higher scores indicate greater food insecurity.
  measure: Estimated Glomerular Filtration Rate (eGFR)
  time frame: As available 18 months before enrollment in the study and 15 months after study participation ends
  description: 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.
  arm group label: Arm 1: Intervention + usual care
  arm group type: Experimental
  description: Welcome package
  Welcome information: telephone call
  Produce delivered at their choice of time and location + Recipes customized to produce
  E-gift cards to a grocery store of choice
  Personalized practical, emotional & educational support through a dedicated health partner
  arm group label: Arm 2: Educational materials + usual care
  arm group type: Other
  description: Welcome package
  Welcome information: SMS/Text
  intervention type: Behavioral
  intervention name: 1. Welcome package
  description: 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
  arm group label: Arm 1: Intervention + usual care
  arm group label: Arm 2: Educational materials + usual care
  intervention type: Behavioral
  intervention name: 2. Welcome information (phone or text)
  description: 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.
  arm group label: Arm 1: Intervention + usual care
  arm group label: Arm 2: Educational materials + usual care
  intervention type: Behavioral
  intervention name: 3. Produce delivery + Recipes customized to produce
  description: 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:
  Weeks 1-2 (2 weeks): No bags delivered.
  Weeks 3-10 (8 weeks): Delivered weekly, for a total of 8 bags.
  Weeks 11-18 (8 weeks): Delivered every two weeks, for a total of 4 bags.
  Weeks 19-26 (8 weeks): No bags delivered.
  arm group label: Arm 1: Intervention + usual care
  intervention type: Behavioral
  intervention name: 4. E-gift cards to a grocery store of choice
  description: Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency:
  Weeks 1-6: No e-gift card.
  Week 7: One card of USD 30.00 value.
  Week 11 & 15: One card of USD 40.00, for a total of USD 80.00.
  Week 19 & 23: One card of USD 60.00, for a total of USD 120.00.
  arm group label: Arm 1: Intervention + usual care
  intervention type: Behavioral
  intervention name: 5. Personalized practical & emotional support through a dedicated health partner
  description: 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:
  Weeks 1-2 (2 weeks): No calls.
  Weeks 3-7 (4 weeks): 2 calls a week, for a total of 8 calls.
  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.
  arm group label: Arm 1: Intervention + usual care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maninder Kahlon, PhD
  role: Principal Investigator
  affiliation: University of Texas at Austin
  last name: Courtney Mulligan, MA
  phone: 512-522-4349
  email: Courtney.Mulligan@austin.utexas.edu
  last name: Nicole Clark, MBA
  phone: 210-316-5443
  email: nicole.clark@austin.utexas.edu
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas at Austin
  investigator full name: Maninder Kahlon
  investigator title: Associate Professor, Population Health
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  provided document: 