<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/NCT03015480</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0382</org_study_id>
    <nct_id>NCT03015480</nct_id>
  </id_info>
  <brief_title>Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes</brief_title>
  <acronym>FitKidney</acronym>
  <official_title>Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geisinger Clinic</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 pilot study tests the feasibility of dietary app-supported tele-counseling in the&#xD;
      treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using&#xD;
      MyFitnessPal on their smartphone or computer to log meal data daily, weekly website&#xD;
      educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients&#xD;
      receive a follow-up phone call from the dietitian and 5 and 11 months for further support and&#xD;
      counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot&#xD;
      study examines the feasibility of dietary app-supported tele-counseling in the treatment of&#xD;
      patients with stage 1-3a chronic kidney disease (CKD) and diabetes.&#xD;
&#xD;
      Main outcomes include sodium intake assessed by 24 hour urine collection as well as other&#xD;
      dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index&#xD;
      score, 24-hour urine phosphorus, estimated net endogenous acid production) and health&#xD;
      measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">November 25, 2018</completion_date>
  <primary_completion_date type="Actual">November 25, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-hour urine sodium</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>unadjusted and adjusted for creatinine excretion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour Ambulatory Systolic Blood Pressure</measure>
    <time_frame>baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine sodium/potassium ratio</measure>
    <time_frame>baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Healthy Eating Index (HEI) score</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Assessed by three 24-hour dietary recalls obtained by phone at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour Urine Albumin Excretion</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>unadjusted and adjusted for creatinine excretion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour urine phosphorus</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>unadjusted and adjusted for creatinine excretion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Net Endogenous Acid Production (NEAP)</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Albuminuria</condition>
  <arm_group>
    <arm_group_label>Remote counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Remote counseling</intervention_name>
    <description>For an 8 week period, patients will be asked to enter dietary information into the MyFitnessPal mobile application or website. Dietitians will access this information and provide personalized motivational interview phone calls on a weekly basis. After the initial 8 weeks, patients will receive a dietitian follow-up phone call around 5 and 11 months later.</description>
    <arm_group_label>Remote counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 21 years&#xD;
&#xD;
          -  Diabetes diagnosis (Type I or Type II)&#xD;
&#xD;
          -  Last urine albumin/creatinine ratio (ACR) within the past two years &gt; 30 mg/g&#xD;
&#xD;
          -  Last outpatient estimated glomerular filtration rate (eGFR) within the past year &gt; 45&#xD;
             ml/min/1.73m2&#xD;
&#xD;
          -  Last outpatient systolic blood pressure (SBP) within the past year &lt; 160 mmHg&#xD;
&#xD;
          -  Last outpatient diastolic blood pressure (DBP) within the past year &lt;100 mmHg&#xD;
&#xD;
          -  Preceding eGFR decline rate less than -2 ml/min/1.73m2/y&#xD;
&#xD;
          -  At least 2 outpatient eGFR measurements in electronic health record, separated by at&#xD;
             least 2 years&#xD;
&#xD;
          -  Agreeable to change diet (decrease sodium and red/processed meat intake, increase&#xD;
             fruit and vegetable intake)&#xD;
&#xD;
          -  Access to smartphone or computer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand English&#xD;
&#xD;
          -  Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure&#xD;
             within 6 months.&#xD;
&#xD;
          -  Current treatment for malignancy&#xD;
&#xD;
          -  Planned bariatric surgery&#xD;
&#xD;
          -  Pregnancy or planning to become pregnant within next 2 years&#xD;
&#xD;
          -  Self-reported average consumption of &gt; 14 alcoholic beverages per week&#xD;
&#xD;
          -  Psychiatric hospitalization in past year&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Urine ACR &gt; 2500 mg/g&#xD;
&#xD;
          -  Last potassium &gt; 5.0 mg/dL&#xD;
&#xD;
          -  Hypoglycemia episode in past 1 month (glucose &lt; 70 mg/dL)&#xD;
&#xD;
          -  Principal investigator discretion (i.e. concerns about safety, compliance)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alex Chang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Wyoming Valley Medical Center</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mobile Application</keyword>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Albuminuria</keyword>
  <keyword>Diet</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>
    <mesh_term>Albuminuria</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03015480
org study id: 2016-0382
nct id: NCT03015480
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study tests the feasibility of dietary app-supported tele-counseling in the
      treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using
      MyFitnessPal on their smartphone or computer to log meal data daily, weekly website
      educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients
      receive a follow-up phone call from the dietitian and 5 and 11 months for further support and
      counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot
      study examines the feasibility of dietary app-supported tele-counseling in the treatment of
      patients with stage 1-3a chronic kidney disease (CKD) and diabetes.

      Main outcomes include sodium intake assessed by 24 hour urine collection as well as other
      dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index
      score, 24-hour urine phosphorus, estimated net endogenous acid production) and health
      measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in 24-hour urine sodium
time frame: baseline to 12 months
description: unadjusted and adjusted for creatinine excretion
measure: Change in 24-hour Ambulatory Systolic Blood Pressure
time frame: baseline to 12 months
measure: Change in urine sodium/potassium ratio
time frame: baseline to 12 months
measure: Change in Healthy Eating Index (HEI) score
time frame: baseline to 12 months
description: Assessed by three 24-hour dietary recalls obtained by phone at each time point
measure: Change in 24-hour Urine Albumin Excretion
time frame: baseline to 12 months
description: unadjusted and adjusted for creatinine excretion
measure: Change in weight
time frame: baseline to 12 months
measure: Change in 24-hour urine phosphorus
time frame: baseline to 12 months
description: unadjusted and adjusted for creatinine excretion
measure: Change in Net Endogenous Acid Production (NEAP)
time frame: baseline to 12 months
description: NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])
arm group label: Remote counseling
arm group type: Experimental
description: This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.
intervention type: Behavioral
intervention name: Remote counseling
description: For an 8 week period, patients will be asked to enter dietary information into the MyFitnessPal mobile application or website. Dietitians will access this information and provide personalized motivational interview phone calls on a weekly basis. After the initial 8 weeks, patients will receive a dietitian follow-up phone call around 5 and 11 months later.
arm group label: Remote counseling
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Alex Chang, MD
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Albuminuria
mesh term: Diabetes Mellitus
sharing ipd: No