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

February 27, 2019 updated by: Geisinger Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour urine sodium
Time Frame: baseline to 12 months
unadjusted and adjusted for creatinine excretion
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour Ambulatory Systolic Blood Pressure
Time Frame: baseline to 12 months
baseline to 12 months
Change in urine sodium/potassium ratio
Time Frame: baseline to 12 months
baseline to 12 months
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
baseline to 12 months
Change in 24-hour Urine Albumin Excretion
Time Frame: baseline to 12 months
unadjusted and adjusted for creatinine excretion
baseline to 12 months
Change in weight
Time Frame: baseline to 12 months
baseline to 12 months
Change in 24-hour urine phosphorus
Time Frame: baseline to 12 months
unadjusted and adjusted for creatinine excretion
baseline to 12 months
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])
baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Alex Chang, MD, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Actual)

November 25, 2018

Study Completion (Actual)

November 25, 2018

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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