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

Primary Purpose

Chronic Kidney Disease, Diabetes Mellitus, Albuminuria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote counseling
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Albuminuria, Diet

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Geisinger Medical Center
  • Geisinger Wyoming Valley Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote counseling

Arm Description

This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.

Outcomes

Primary Outcome Measures

Change in 24-hour urine sodium
unadjusted and adjusted for creatinine excretion

Secondary Outcome Measures

Change in 24-hour Ambulatory Systolic Blood Pressure
Change in urine sodium/potassium ratio
Change in Healthy Eating Index (HEI) score
Assessed by three 24-hour dietary recalls obtained by phone at each time point
Change in 24-hour Urine Albumin Excretion
unadjusted and adjusted for creatinine excretion
Change in weight
Change in 24-hour urine phosphorus
unadjusted and adjusted for creatinine excretion
Change in Net Endogenous Acid Production (NEAP)
NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])

Full Information

First Posted
January 4, 2017
Last Updated
February 27, 2019
Sponsor
Geisinger Clinic
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03015480
Brief Title
Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
Acronym
FitKidney
Official Title
Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
November 25, 2018 (Actual)
Study Completion Date
November 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
Collaborators
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Diabetes Mellitus, Albuminuria
Keywords
Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Albuminuria, Diet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote counseling
Arm Type
Experimental
Arm 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(s)
Remote counseling
Intervention 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.
Primary Outcome Measure Information:
Title
Change in 24-hour urine sodium
Description
unadjusted and adjusted for creatinine excretion
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in 24-hour Ambulatory Systolic Blood Pressure
Time Frame
baseline to 12 months
Title
Change in urine sodium/potassium ratio
Time Frame
baseline to 12 months
Title
Change in Healthy Eating Index (HEI) score
Description
Assessed by three 24-hour dietary recalls obtained by phone at each time point
Time Frame
baseline to 12 months
Title
Change in 24-hour Urine Albumin Excretion
Description
unadjusted and adjusted for creatinine excretion
Time Frame
baseline to 12 months
Title
Change in weight
Time Frame
baseline to 12 months
Title
Change in 24-hour urine phosphorus
Description
unadjusted and adjusted for creatinine excretion
Time Frame
baseline to 12 months
Title
Change in Net Endogenous Acid Production (NEAP)
Description
NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])
Time Frame
baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Chang, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34649784
Citation
Schrauben SJ, Inamdar A, Yule C, Kwiecien S, Krekel C, Collins C, Anderson C, Bailey-Davis L, Chang AR. Effects of Dietary App-Supported Tele-Counseling on Sodium Intake, Diet Quality, and Blood Pressure in Patients With Diabetes and Kidney Disease. J Ren Nutr. 2022 Jan;32(1):39-50. doi: 10.1053/j.jrn.2021.08.006. Epub 2021 Oct 11.
Results Reference
derived

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

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