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Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes (FitKidney)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015480
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Geisinger Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Diabetes Mellitus Albuminuria Behavioral: Remote counseling Not Applicable

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : November 25, 2018
Actual Study Completion Date : November 25, 2018

Arm Intervention/treatment
Experimental: Remote counseling
This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.
Behavioral: Remote counseling
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.




Primary Outcome Measures :
  1. Change in 24-hour urine sodium [ Time Frame: baseline to 12 months ]
    unadjusted and adjusted for creatinine excretion


Secondary Outcome Measures :
  1. Change in 24-hour Ambulatory Systolic Blood Pressure [ Time Frame: baseline to 12 months ]
  2. Change in urine sodium/potassium ratio [ Time Frame: baseline to 12 months ]
  3. Change in Healthy Eating Index (HEI) score [ Time Frame: baseline to 12 months ]
    Assessed by three 24-hour dietary recalls obtained by phone at each time point

  4. Change in 24-hour Urine Albumin Excretion [ Time Frame: baseline to 12 months ]
    unadjusted and adjusted for creatinine excretion

  5. Change in weight [ Time Frame: baseline to 12 months ]
  6. Change in 24-hour urine phosphorus [ Time Frame: baseline to 12 months ]
    unadjusted and adjusted for creatinine excretion

  7. Change in Net Endogenous Acid Production (NEAP) [ Time Frame: baseline to 12 months ]
    NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 21 years
  • Diabetes diagnosis (Type I or Type II)
  • Last urine albumin/creatinine ratio (ACR) within the past two years > 30 mg/g
  • Last outpatient estimated glomerular filtration rate (eGFR) within the past year > 45 ml/min/1.73m2
  • Last outpatient systolic blood pressure (SBP) within the past year < 160 mmHg
  • Last outpatient diastolic blood pressure (DBP) within the past year <100 mmHg
  • Preceding eGFR decline rate less than -2 ml/min/1.73m2/y
  • At least 2 outpatient eGFR measurements in electronic health record, separated by at least 2 years
  • Agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake)
  • Access to smartphone or computer

Exclusion Criteria:

  • Inability to understand English
  • Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months.
  • Current treatment for malignancy
  • Planned bariatric surgery
  • Pregnancy or planning to become pregnant within next 2 years
  • Self-reported average consumption of > 14 alcoholic beverages per week
  • Psychiatric hospitalization in past year
  • Unstable angina
  • Urine ACR > 2500 mg/g
  • Last potassium > 5.0 mg/dL
  • Hypoglycemia episode in past 1 month (glucose < 70 mg/dL)
  • Principal investigator discretion (i.e. concerns about safety, compliance)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015480


Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Sponsors and Collaborators
Geisinger Clinic
Johns Hopkins University
Investigators
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Principal Investigator: Alex Chang, MD Geisinger Clinic
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Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03015480    
Other Study ID Numbers: 2016-0382
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geisinger Clinic:
Mobile Application
Chronic Kidney Disease
Diabetes Mellitus
Albuminuria
Diet
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations